<?xml version="1.0" encoding="UTF-8"?><!DOCTYPE article PUBLIC "-//NLM//DTD JATS (Z39.96) Journal Publishing DTD v1.2 20190208//EN" "http://jats.nlm.nih.gov/publishing/1.2/JATS-journalpublishing1.dtd"><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" article-type="other" dtd-version="1.2" xml:lang="en">
    <front>
        <journal-meta>
            <journal-id journal-id-type="pmc">F1000Research</journal-id>
            <journal-title-group>
                <journal-title>F1000Research</journal-title>
            </journal-title-group>
            <issn pub-type="epub">2046-1402</issn>
            <publisher>
                <publisher-name>F1000 Research Limited</publisher-name>
                <publisher-loc>London, UK</publisher-loc>
            </publisher>
        </journal-meta>
        <article-meta>
            <article-id pub-id-type="doi">10.12688/f1000research.144479.1</article-id>
            <article-categories>
                <subj-group subj-group-type="heading">
                    <subject>Study Protocol</subject>
                </subj-group>
                <subj-group>
                    <subject>Articles</subject>
                </subj-group>
            </article-categories>
            <title-group>
                <article-title>Comparison of USG guided with Anatomical Landmark guided TAP Block following Total Abdominal Hysterectomy</article-title>
                <fn-group content-type="pub-status">
                    <fn>
                        <p>[version 1; peer review: 1 approved with reservations]</p>
                    </fn>
                </fn-group>
            </title-group>
            <contrib-group>
                <contrib contrib-type="author" corresp="yes">
                    <name>
                        <surname>GHOSH</surname>
                        <given-names>ANGAN</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Conceptualization</role>
                    <role content-type="http://credit.niso.org/">Investigation</role>
                    <role content-type="http://credit.niso.org/">Methodology</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Original Draft Preparation</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <uri content-type="orcid">https://orcid.org/0009-0008-4418-3722</uri>
                    <xref ref-type="corresp" rid="c1">a</xref>
                    <xref ref-type="aff" rid="a1">1</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Ninave</surname>
                        <given-names>Dr. Sanjot</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Project Administration</role>
                    <role content-type="http://credit.niso.org/">Supervision</role>
                    <role content-type="http://credit.niso.org/">Validation</role>
                    <role content-type="http://credit.niso.org/">Visualization</role>
                    <xref ref-type="aff" rid="a1">1</xref>
                </contrib>
                <aff id="a1">
                    <label>1</label>DEPARTMENT OF ANAESTHESIA, JAWAHARLAL NEHRU MEDICAL COLLEGE , DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH, WARDHA, MAHARASHTRA, 442001, India</aff>
            </contrib-group>
            <author-notes>
                <corresp id="c1">
                    <label>a</label>
                    <email xlink:href="mailto:angan.ghosh05@gmail.com">angan.ghosh05@gmail.com</email>
                </corresp>
                <fn fn-type="conflict">
                    <p>No competing interests were disclosed.</p>
                </fn>
            </author-notes>
            <pub-date pub-type="epub">
                <day>7</day>
                <month>3</month>
                <year>2024</year>
            </pub-date>
            <pub-date pub-type="collection">
                <year>2024</year>
            </pub-date>
            <volume>13</volume>
            <elocation-id>160</elocation-id>
            <history>
                <date date-type="accepted">
                    <day>15</day>
                    <month>2</month>
                    <year>2024</year>
                </date>
            </history>
            <permissions>
                <copyright-statement>Copyright: &#x00a9; 2024 GHOSH A and Ninave DS</copyright-statement>
                <copyright-year>2024</copyright-year>
                <license xlink:href="https://creativecommons.org/licenses/by/4.0/">
                    <license-p>This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</license-p>
                </license>
                <license>
                    <license-p>The author(s) is/are employees of the US Government and therefore domestic copyright protection in USA does not apply to this work. The work may be protected under the copyright laws of other jurisdictions when used in those jurisdictions.</license-p>
                </license>
            </permissions>
            <self-uri content-type="pdf" xlink:href="https://f1000research.com/articles/13-160/pdf"/>
            <abstract>
                <p>A crucial part of a multimodal anaesthetic strategy utilized to accelerate recovery following lower abdominal procedures is the Transversus Abdominis Plane (TAP) Block. The TAP Block is administered in the petit triangle, with its base being formed by the iliac crest, the external oblique in front of it, and the latissimus dorsi at its rear. The intercostal, subcostal, iliohypogastric, and ilioinguinal nerves are housed in this interfascial plane. The TAP block reduces pain from the incision site during both inpatient and outpatient surgical procedures, as well as open and laparoscopic abdominal operations, by obstructing sensory signals from the nerves providing the anterior wall of the abdomen (anterior division of the segment of the spinal cord responsible for T6-L1). Postoperative pain can be effectively alleviated with TAP blocks. Through the use of supplementary drugs such as opioids, opioid agonist antagonists, ketamine, and alpha-2 agonists, including Nalbuphine, clonidine, and dexmedetomidine in blockade of peripheral nerves and field blocks, the duration of pain relief following surgery can be extended. Specifically, a combination of 10 mg of Nalbuphine and bupivacaine, on either side with a volume of 20 ml, improves patient comfort and pain management, allows for early patient mobilization, prolongs postsurgical pain relief, and lowers the need for rescue analgesia. This research aims to assess the efficacy of the Anatomical Landmark against Ultrasound-Guided TAP Block for patients undergoing Total Abdominal Hysterectomy under Subarachnoid Block.</p>
            </abstract>
            <kwd-group kwd-group-type="author">
                <kwd>Nalbuphine</kwd>
                <kwd>Transversus Abdominis Plane Block</kwd>
                <kwd>Anatomical Landmark</kwd>
                <kwd>Total Abdominal Hysterectomy</kwd>
                <kwd>Bupivacaine</kwd>
                <kwd>Subarachnoid Block</kwd>
                <kwd>Postoperative pain.</kwd>
            </kwd-group>
            <funding-group>
                <funding-statement>The author(s) declared that no grants were involved in supporting this work.</funding-statement>
            </funding-group>
        </article-meta>
    </front>
    <body>
        <sec id="sec1" sec-type="intro">
            <title>Introduction</title>
            <p>Most surgical patients frequently experience soreness following their surgery. Effective pain management is essential for the patient to begin normal activities earlier and prevents severe physiological and psychological effects that could arise from uncontrolled postoperative pain. The main goals of postsurgical pain relief are to mitigate the adverse effects of acute pain after surgery and enable a smoother return to normal functioning.
                <sup>
                    <xref ref-type="bibr" rid="ref1">1</xref>
                </sup> Opioid analgesic medications have been used as the mainstay of postoperative pain treatment. There is an increasing need for research into pain management techniques which employ a multimodal strategy, given the recent increase in fatalities and morbidity related to opioid addiction.
                <sup>
                    <xref ref-type="bibr" rid="ref2">2</xref>
                </sup>
            </p>
            <p>The Transversus Abdominis Plane (TAP) block is a component of a comprehensive anaesthetic approach intended to provide both visceral and somatic analgesia and expedite recovery from lower abdominal procedures. Anatomical landmarks like the Triangle of Petit or ultrasound guidance can be utilized for delivering the TAP block.
                <sup>
                    <xref ref-type="bibr" rid="ref3">3</xref>
                </sup> The duration of postoperative pain relief can be extended by combining local anaesthetics such as bupivacaine with adjuvants like the opioid agonist-antagonist Nalbuphine.
                <sup>
                    <xref ref-type="bibr" rid="ref4">4</xref>
                </sup> Compared to the anatomical landmark technique employing the Triangle of Petit, ultrasound guidance for the TAP block ensures a quicker onset of action, lowers the chance of failures, requires a lesser volume of drug, and prolongs the duration of effect.
                <sup>
                    <xref ref-type="bibr" rid="ref5">5</xref>
                </sup>
            </p>
            <p>To evaluate the comparative efficacy of anatomical landmark technique and ultrasound-guided TAP block in terms of postoperative analgesic effects following total abdominal hysterectomy, this study will use injections of 0.25% Bupivacaine along with 10 mg Nalbuphine to make an overall volume of 20 ml on each side. The period of analgesia is the primary outcome measure. The duration of sensory block, variations in hemodynamic parameters, the frequency of block failures, the time to administer the first rescue analgesics, and adverse effects will constitute secondary outcomes.</p>
            <sec id="sec2">
                <title>Aim</title>
                <p>To compare the efficacy of USG Guided with Anatomical landmark guided TAP Block using Injection Bupivacaine 0.25% with Injection Nalbuphine 10 mg, total volume 20 ml on each side, following Total abdominal hysterectomy.</p>
            </sec>
            <sec id="sec3">
                <title>Objectives</title>
                <p>
                    <list list-type="order">
                        <list-item>
                            <label>1.</label>
                            <p>Primary Objectives</p>
                            <list list-type="bullet">
                                <list-item>
                                    <label>&#x25cb;</label>
                                    <p>To compare the efficacy of USG guided with Anatomical landmark guided TAP block following Total abdominal hysterectomy.</p>
                                </list-item>
                            </list>
                        </list-item>
                        <list-item>
                            <label>2.</label>
                            <p>Secondary objectives</p>
                            <list list-type="bullet">
                                <list-item>
                                    <label>&#x25cb;</label>
                                    <p>Duration of analgesia with USG guided technique and Anatomical landmark technique,</p>
                                </list-item>
                                <list-item>
                                    <label>&#x25cb;</label>
                                    <p>Number of failures of the block with both techniques,</p>
                                </list-item>
                                <list-item>
                                    <label>&#x25cb;</label>
                                    <p>Time to administration of rescue analgesia to the patient (VAS&gt;4),</p>
                                </list-item>
                                <list-item>
                                    <label>&#x25cb;</label>
                                    <p>Any side effects.</p>
                                </list-item>
                            </list>
                        </list-item>
                    </list>
                </p>
            </sec>
        </sec>
        <sec id="sec4" sec-type="methods">
            <title>Methods</title>
            <p>The research will be conducted in the JNMC Department of Anaesthesiology, Datta Meghe Institute of Higher Education &amp; Research, Sawangi (M), Wardha. The DMIHER Institutional Ethics Committee has granted approval for the research [Ref.No. DMIHER (DU)/IEC/2023/888] on 31
                <sup>st</sup> March, 2023. We shall obtain the participants&#x2019; signed informed consent before the commencement of the study. A departmental steering group will also supervise and track the study&#x2019;s advancement until its completion.</p>
            <p>Research design &#x2013; Prospective, comparative design.</p>
            <p>Study area &#x2013; Department of Anaesthesiology JNMC &amp; AVBRH.</p>
            <p>Study period &#x2013; 2 years</p>
            <p>Patient allotment &#x2013; Computer-generated randomization.</p>
            <p>Study population &#x2013; Patients undergoing Total Abdominal Hysterectomy surgeries.</p>
            <sec id="sec5">
                <title>Inclusion criteria</title>
                <p>
                    <list list-type="bullet">
                        <list-item>
                            <label>-</label>
                            <p>Participants will include females between the ages of 35 and 70,</p>
                        </list-item>
                        <list-item>
                            <label>-</label>
                            <p>Patients scheduled to have Total Abdominal Hysterectomy (TAH),</p>
                        </list-item>
                        <list-item>
                            <label>-</label>
                            <p>The surgery is expected to take place between one to three hours,</p>
                        </list-item>
                        <list-item>
                            <label>-</label>
                            <p>Patients classified as either grade I or II ASA or stage I or II MPC,</p>
                        </list-item>
                        <list-item>
                            <label>-</label>
                            <p>Patients who meet the requirements for a Transversus Abdominis Plane (TAP) block,</p>
                        </list-item>
                        <list-item>
                            <label>-</label>
                            <p>Patients whose body weight is equal to or more than 50 kg,</p>
                        </list-item>
                        <list-item>
                            <label>-</label>
                            <p>Patients indicating a desire to take part in the study.</p>
                        </list-item>
                    </list>
                </p>
            </sec>
            <sec id="sec6">
                <title>Exclusion criteria</title>
                <p>
                    <list list-type="bullet">
                        <list-item>
                            <label>-</label>
                            <p>Lack of a legitimate, documented, and informed consent,</p>
                        </list-item>
                        <list-item>
                            <label>-</label>
                            <p>Patients falling into ASA grades III and IV,</p>
                        </list-item>
                        <list-item>
                            <label>-</label>
                            <p>Patients weighing less than or equal to 50 kg,</p>
                        </list-item>
                        <list-item>
                            <label>-</label>
                            <p>Patients with neurological and musculoskeletal disorders,</p>
                        </list-item>
                        <list-item>
                            <label>-</label>
                            <p>Patients with bleeding disorders, patients currently taking anticoagulant medication,</p>
                        </list-item>
                        <list-item>
                            <label>-</label>
                            <p>Patients with documented allergies to local anaesthetics and Nalbuphine injections.</p>
                        </list-item>
                    </list>
                </p>
            </sec>
            <sec id="sec7">
                <title>Sample size calculation</title>
                <p>Formula using Mean difference
                    <disp-formula id="e1">
                        <mml:math display="block">
                            <mml:mi mathvariant="normal">n</mml:mi>
                            <mml:mn>1</mml:mn>
                            <mml:mo>=</mml:mo>
                            <mml:mi mathvariant="normal">n</mml:mi>
                            <mml:mn>2</mml:mn>
                            <mml:mo>=</mml:mo>
                            <mml:mn>2</mml:mn>
                            <mml:mfrac>
                                <mml:mrow>
                                    <mml:msup>
                                        <mml:mfenced close=")" open="(">
                                            <mml:mrow>
                                                <mml:msub>
                                                    <mml:mi mathvariant="normal">z</mml:mi>
                                                    <mml:mi mathvariant="normal">a</mml:mi>
                                                </mml:msub>
                                                <mml:mo>+</mml:mo>
                                                <mml:msub>
                                                    <mml:mi mathvariant="normal">z</mml:mi>
                                                    <mml:mi mathvariant="normal">&#x03b2;</mml:mi>
                                                </mml:msub>
                                            </mml:mrow>
                                        </mml:mfenced>
                                        <mml:mn>2</mml:mn>
                                    </mml:msup>
                                    <mml:msup>
                                        <mml:mi mathvariant="normal">&#x03c3;</mml:mi>
                                        <mml:mn>2</mml:mn>
                                    </mml:msup>
                                </mml:mrow>
                                <mml:msup>
                                    <mml:mfenced close=")" open="(">
                                        <mml:mi mathvariant="normal">&#x03c3;</mml:mi>
                                    </mml:mfenced>
                                    <mml:mn>2</mml:mn>
                                </mml:msup>
                            </mml:mfrac>
                        </mml:math>
                    </disp-formula>
                </p>
                <p>Z&#x03b1; = 1.96</p>
                <p>&#x03b1; = Type 1 error at 5% at both sides two tailed</p>
                <p>Z&#x03b2; = 1.645 = Power at 95%</p>
                <p>Primary variable TUG Time to first rescue</p>
                <p>Time to first rescue analgesia group 1 Mean Value = 11.87</p>
                <p>Time to first rescue analgesia group 2 Mean Value = 9.67</p>
                <p>Mean Difference = 2.20 (As Per Reference article)</p>
                <p>Standard Deviation = (2.97+ 2.47)/2 = 2.72 (As Per Reference article)
                    <disp-formula id="e2">
                        <mml:math display="block">
                            <mml:mtext>Sample size</mml:mtext>
                            <mml:mspace width="0.25em"/>
                            <mml:mi mathvariant="normal">N</mml:mi>
                            <mml:mo>=</mml:mo>
                            <mml:mi>n</mml:mi>
                            <mml:mn>1</mml:mn>
                            <mml:mo>=</mml:mo>
                            <mml:mi>n</mml:mi>
                            <mml:mn>2</mml:mn>
                            <mml:mo>=</mml:mo>
                            <mml:mn>2</mml:mn>
                            <mml:mfrac>
                                <mml:mrow>
                                    <mml:msup>
                                        <mml:mfenced close=")" open="(">
                                            <mml:mrow>
                                                <mml:mn>1</mml:mn>
                                                <mml:mo>&#x00b7;</mml:mo>
                                                <mml:mn>96</mml:mn>
                                                <mml:mo>+</mml:mo>
                                                <mml:mn>1</mml:mn>
                                                <mml:mo>&#x00b7;</mml:mo>
                                                <mml:mn>64</mml:mn>
                                            </mml:mrow>
                                        </mml:mfenced>
                                        <mml:mn>2</mml:mn>
                                    </mml:msup>
                                    <mml:msup>
                                        <mml:mfenced close=")" open="(">
                                            <mml:mrow>
                                                <mml:mn>2</mml:mn>
                                                <mml:mo>&#x00b7;</mml:mo>
                                                <mml:mn>72</mml:mn>
                                            </mml:mrow>
                                        </mml:mfenced>
                                        <mml:mn>2</mml:mn>
                                    </mml:msup>
                                </mml:mrow>
                                <mml:msup>
                                    <mml:mfenced close=")" open="(">
                                        <mml:mn>2.20</mml:mn>
                                    </mml:mfenced>
                                    <mml:mn>2</mml:mn>
                                </mml:msup>
                            </mml:mfrac>
                            <mml:mo>=</mml:mo>
                            <mml:mn>26</mml:mn>
                            <mml:mspace width="0.25em"/>
                            <mml:mtext>per group</mml:mtext>
                        </mml:math>
                    </disp-formula>
                    <disp-formula id="e3">
                        <mml:math display="block">
                            <mml:mtext>Considering 20% drop out</mml:mtext>
                            <mml:mo>=</mml:mo>
                            <mml:mn>5</mml:mn>
                        </mml:math>
                    </disp-formula>
                    <disp-formula id="e4">
                        <mml:math display="block">
                            <mml:mtext>Total sample size required</mml:mtext>
                            <mml:mspace width="0.25em"/>
                            <mml:mn>26</mml:mn>
                            <mml:mo>+</mml:mo>
                            <mml:mn>5</mml:mn>
                            <mml:mo>=</mml:mo>
                            <mml:mn>31</mml:mn>
                            <mml:mspace width="0.25em"/>
                            <mml:mi>per</mml:mi>
                            <mml:mspace width="0.25em"/>
                            <mml:mtext>group</mml:mtext>
                            <mml:mo>.</mml:mo>
                        </mml:math>
                    </disp-formula>
                </p>
                <p>Reference Article: Kapil Prajapati et al.
                    <sup>
                        <xref ref-type="bibr" rid="ref6">6</xref>
                    </sup>
                </p>
                <p>The research will involve 60 patients who fulfil the criteria for inclusion in the study. The following study groups will be assigned to patients for the study:
                    <list list-type="bullet">
                        <list-item>
                            <label>&#x2022;</label>
                            <p>Group U &#x2013; 30 patients will receive Bupivacaine 0.5% (10 ml) + Nalbuphine 10 mg (1 ml) + 9 ml normal saline injected under the USG guided technique. Total volume: 20 millilitres on each side (bilateral).</p>
                        </list-item>
                        <list-item>
                            <label>&#x2022;</label>
                            <p>Group A &#x2013; 30 patients will receive Bupivacaine 0.5% (10 ml) + Nalbuphine 10 mg (1 ml) + 9 ml normal saline injected via anatomical landmark technique. Total volume: 20 millilitres on each side (bilateral).</p>
                        </list-item>
                    </list>
                </p>
            </sec>
        </sec>
        <sec id="sec9" sec-type="methods">
            <title>Methods</title>
            <p>A pre-operative evaluation will be performed on each patient one day preceding the surgery. Relevant patient data, such as demographics, medical history, current symptoms, and a thorough physical examination, will be requested. Appropriate laboratory tests and blood tests will be ordered. The study&#x2019;s goals, advantages, and possible disadvantages will be explained to the patients. Each patient who wishes to participate in the study must provide written informed consent. Prior to surgery, patients have to follow a minimum eight-hour fasting period. An electrocardiography (ECG), blood pressure monitor, and an oxygen saturation probe will be affixed to the patient on the day of the surgery and baseline vital parameters will be constantly monitored. After securing an 18-gauge intravenous (IV) line, 10 to 15 millilitres of Ringer lactate solution will be injected intravenously per kilogram. A 75&#x2013;100 mcg/kg injection of ondansetron will be injected intravenously ten minutes before the anaesthetic procedure. The patients will be administered spinal anaesthesia under strict aseptic precautions at L3-L4 interspace. After the abdomen is closed following the total abdominal hysterectomy performed under a subarachnoid block with 3.5 millilitres of 0.5% bupivacaine, the TAP block will be administered based on the study groups to which the patient belongs. If the patient is conscious, lignocaine will be used to anaesthetize their skin before a 21-gauge block needle will be inserted to identify the TAP compartment via the Triangle of Petit or sonographically utilizing an ultrasound probe.
                <list list-type="order">
                    <list-item>
                        <label>1.</label>
                        <p>Anatomical Landmark guided technique - A solid grasp of both the surface and interior anatomical parts in the above technique. Locating the Triangle of Petit can be accomplished by palpating the rim of the pelvis along the mid-axillary line. The lower boundary of this triangle is represented by the iliac crest. The front boundary of the triangle is defined by the external oblique muscle. The rear boundary of the triangle is defined by the latissimus dorsi muscle. Once these borders have been appropriately established, along with the necessary draping and preparations, a short, bevelled 21-gauge needle is inserted into the skin perpendicularly. During the procedure, there are two distinct pops. The first pop is associated with it passing through fascia of the external oblique, whereas the second pop happens as the needle passes the fascia of the internal oblique. In case aspiration proves unsuccessful, a 20 ml mixture of 10 mg nalbuphine and 0.25% bupivacaine will be subtly injected.</p>
                    </list-item>
                    <list-item>
                        <label>2.</label>
                        <p>Ultrasound-guided technique - In order to visualise the abdominal wall muscles (transversus abdominis, internal oblique, and external oblique), as well as deeper structures like the peritoneum and viscera, the ultrasonic probe should be positioned transversely between the subcostal border and the iliac crest, following the anterior axillary line. In ultrasound-guided procedures, the needle tip will be continually visualised during the procedure. Once the needle is located in the plane that is found between the transversus abdominis and internal oblique muscles and a negative blood aspiration has been obtained, a gentle injection of 20 ml of 10 mg nalbuphine and 0.25% bupivacaine will be administered.</p>
                    </list-item>
                </list>
            </p>
            <p>In both techniques, the transversus abdominis and rectus abdominis muscles will separate as the drug is administered, allowing the TAP compartment to be dissected.
                <sup>
                    <xref ref-type="bibr" rid="ref7">7</xref>
                </sup> Postoperative pain reduction will be achieved with the prompt administration of the TAP Block following the surgical operation.
                <sup>
                    <xref ref-type="bibr" rid="ref8">8</xref>
                </sup> Primary parameters deciding the efficacy of the procedure such as the hemodynamic parameters, time taken for the drug to act, cost-effectiveness, effectiveness of the block whether partial or total block, patient satisfaction etc. will be noted down and data analysis will be done. It is noteworthy that the TAP Block covers a non-dermatomal field. We will take note of the following information - The sensory blockade, level of sedation, postoperative pain relief measured by the visual analogue scale, timing of administration of rescue analgesia, and adverse effects. Patients will be moved to the monitoring ward after the surgery, where they will be observed every 10 minutes, 20 minutes, 30 minutes, 60 minutes, 120 minutes, 150 minutes and 180 minutes after the procedure. In the event that a patient is in severe pain, rescue analgesics will be given. When the patient&#x2019;s pain level, as measured by the Visual Analogue Scale (VAS), reaches four or above, intravenous paracetamol will be administered at a dosage of 15-20 mg per kilogram. In the ultrasound-guided procedure, drug deposition is visualized, and in the anatomical landmark technique, medication flows freely from the needle, confirming the sensory block. The time it takes the patient to request their first dosage of rescue analgesia can be used to estimate the duration of the sensory blockade. The Ramsay Modified Sedation score will assess the degree of sedation during the TAP block and 30 and 60 minutes after it is administered. Following surgery, the patient&#x2019;s sedation score will be assessed every ten minutes for a maximum of 180 minutes and whenever the patient feels pain.</p>
            <sec id="sec10">
                <title>Dissemination</title>
                <p>The study findings will be displayed at relevant conferences and sent for publication in appropriate journals.</p>
            </sec>
            <sec id="sec11">
                <title>Status of the study</title>
                <p>The collection of data is ongoing.</p>
            </sec>
        </sec>
        <sec id="sec12" sec-type="discussion">
            <title>Discussion</title>
            <p>TAP Block is a non-dermatomal field block used to provide relief from both visceral and somatic pain by blocking the nerve inputs from the thoracolumbar spinal nerve plexus, including the intercostal nerves, subcostal nerves, ilioinguinal, and iliohypogastric nerves.
                <sup>
                    <xref ref-type="bibr" rid="ref9">9</xref>
                </sup> In research comparing the efficacy of the USG-guided TAP block to the Anatomical landmark technique for postsurgical analgesia after total abdominal hysterectomy, the USG-guided approach produced better outcomes than the Anatomical landmark technique. The study used 0.25% Bupivacaine and 10mg Nalbuphine, with a volume of twenty ml on each side (bilateral). It demonstrated fewer failures, needed less medication, had a quicker onset of pharmacological effect, and had a longer half-life. By attaching to kappa receptors in the central nervous system, Nalbuphine inhibits the release of pain-related neurotransmitters such as substance P. It also functions as a partial agonist or antagonist at mu receptors and a competitive opioid agonist at kappa receptors. It is an adjuvant to bupivacaine, an amide local anaesthetic that lowers sodium permeability and raises the action potential threshold to impede nerve impulse conduction. Nalbuphine improved the effectiveness of TAP Block and offered better pain management without changing the patients&#x2019; hemodynamic profile. The interval between an injection and a Visual Analogue Scale (VAS) score of less than four was used to measure adequate analgesia. As a prior study has shown, there were no incidences of respiratory depression, drowsiness, nausea, pruritus, or vomiting&#x2014;all commonly linked to mu receptor activity. Moreover, neither of the two evaluated procedures indicated dermatomal involvement in our investigation.</p>
            <p>Patients receiving USG-guided TAP block had considerably low discomfort at rest, with lower VAS scores at four, twelve, and twenty-four hours, and a decreased need for postoperative morphine within the first 24 hours, according to a study comparing USG-guided with blind TAP block in hernia patients.
                <sup>
                    <xref ref-type="bibr" rid="ref10">10</xref>
                </sup> The time to request the first dose of analgesic post surgery was prolonged in the group receiving the USG-guided hernia block (7.22 hours) than in the group receiving the landmark-guided TAP block (6.80 hours) in another study comparing the two procedures.
                <sup>
                    <xref ref-type="bibr" rid="ref11">11</xref>
                </sup>
            </p>
            <p>It was demonstrated in a meticulously executed double-blinded, randomized controlled clinical trial that the addition of twenty milligrams of Nalbuphine in a supraclavicular brachial plexus block with bupivacaine considerably prolonged the length of the motor and sensory blocks, and the period of analgesia.
                <sup>
                    <xref ref-type="bibr" rid="ref12">12</xref>
                </sup>
            </p>
            <p>The research results will highlight the benefits of ultrasound-guided TAP blocks, especially when paired with bupivacaine and Nalbuphine for patients with total abdominal hysterectomy. The findings might prove this method is safe, effective, and linked to extended pain relief, decreased need for opioids, and few adverse effects. This work will add to the increasing amount of data that shows TAP Blocks can be a practical part of multimodal postoperative pain treatment plans.</p>
        </sec>
    </body>
    <back>
        <sec id="sec15" sec-type="data-availability">
            <title>Data availability</title>
            <p>No data are associated with this article.</p>
        </sec>
        <ref-list>
            <title>References</title>
            <ref id="ref1">
                <label>1</label>
                <mixed-citation publication-type="book">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Horn</surname>
                            <given-names>R</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Kramer</surname>
                            <given-names>J</given-names>
                        </name>
</person-group>:
                    <chapter-title>Postoperative Pain Control.</chapter-title>
                    <source>

                        <italic toggle="yes">StatPearls.</italic>
</source>
                    <publisher-loc>Treasure Island (FL)</publisher-loc>:
                    <publisher-name>StatPearls Publishing</publisher-name>;<year>2023 [cited 2024 Jan 13]</year>.</mixed-citation>
            </ref>
            <ref id="ref2">
                <label>2</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Bartels</surname>
                            <given-names>K</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Mayes</surname>
                            <given-names>LM</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Dingmann</surname>
                            <given-names>C</given-names>
                        </name>

                        <etal/>
</person-group>:
                    <article-title>Opioid Use and Storage Patterns by Patients after Hospital Discharge following Surgery. Costigan M, editor.</article-title>
                    <source>

                        <italic toggle="yes">PLoS One.</italic>
</source>
                    <year>2016 Jan 29 [cited 2023 Oct 26]</year>;<volume>11</volume>(<issue>1</issue>):<fpage>e0147972</fpage>.
                    <pub-id pub-id-type="pmid">26824844</pub-id>
                    <pub-id pub-id-type="doi">10.1371/journal.pone.0147972</pub-id>
                    <pub-id pub-id-type="pmcid">PMC4732746</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref3">
                <label>3</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Uppal</surname>
                            <given-names>V</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Sancheti</surname>
                            <given-names>S</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Kalagara</surname>
                            <given-names>H</given-names>
                        </name>
</person-group>:
                    <article-title>Transversus Abdominis Plane (TAP) and Rectus Sheath Blocks: aTechnical Description and Evidence Review.</article-title>
                    <source>

                        <italic toggle="yes">Curr. Anesthesiol. Rep.</italic>
</source>
                    <year>2019 Dec [cited 2022 Sep 1]</year>;<volume>9</volume>(<issue>4</issue>):<fpage>479</fpage>&#x2013;<lpage>487</lpage>.
                    <pub-id pub-id-type="doi">10.1007/s40140-019-00351-y</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref4">
                <label>4</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Raghuraman</surname>
                            <given-names>MS</given-names>
                        </name>
</person-group>:
                    <article-title>Intrathecal nalbuphine &#x2013; Will it gain wider acceptance? &#x2013; A narrative review.</article-title>
                    <source>

                        <italic toggle="yes">Egypt J. Anaesth.</italic>
</source>
                    <year>2017 Jul 1</year>;<volume>33</volume>(<issue>3</issue>):<fpage>289</fpage>&#x2013;<lpage>293</lpage>.
                    <pub-id pub-id-type="doi">10.1016/j.egja.2017.04.003</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref5">
                <label>5</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Hebbard</surname>
                            <given-names>P</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Fujiwara</surname>
                            <given-names>Y</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Shibata</surname>
                            <given-names>Y</given-names>
                        </name>

                        <etal/>
</person-group>:
                    <article-title>Ultrasound-guided transversus abdominis plane (TAP) block.</article-title>
                    <source>

                        <italic toggle="yes">Anaesth. Intensive Care.</italic>
</source>
                    <year>2007 Aug</year>;<volume>35</volume>(<issue>4</issue>):<fpage>616</fpage>&#x2013;<lpage>617</lpage>.
                    <pub-id pub-id-type="pmid">18020088</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref6">
                <label>6</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Prajapati</surname>
                            <given-names>K</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Patel</surname>
                            <given-names>KK</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Baghel</surname>
                            <given-names>H</given-names>
                        </name>

                        <etal/>
</person-group>:
                    <article-title>Ultrasound Guided versus Peripheral Nerve Stimulator Guided Transversus Abdominis Plane Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Cholecystectomy: A Randomised Clinical Study.</article-title>
                    <source>

                        <italic toggle="yes">J. Clin. Diagn. Res.</italic>
</source>
                    <year>2022 [cited 2023 Oct 23</year>.
                    <pub-id pub-id-type="doi">10.7860/JCDR/2022/58292.17014</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref7">
                <label>7</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Barrington</surname>
                            <given-names>MJ</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Ivanusic</surname>
                            <given-names>JJ</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Rozen</surname>
                            <given-names>WM</given-names>
                        </name>

                        <etal/>
</person-group>:
                    <article-title>Spread of injectate after ultrasound-guided subcostal transversus abdominis plane block: a cadaveric study.</article-title>
                    <source>

                        <italic toggle="yes">Anaesthesia.</italic>
</source>
                    <year>2009 Jul [cited 2023 Oct 26]</year>;<volume>64</volume>(<issue>7</issue>):<fpage>745</fpage>&#x2013;<lpage>750</lpage>.
                    <pub-id pub-id-type="pmid">19624629</pub-id>
                    <pub-id pub-id-type="doi">10.1111/j.1365-2044.2009.05933.x</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref8">
                <label>8</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Ganapathy</surname>
                            <given-names>S</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Sondekoppam</surname>
                            <given-names>RV</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Terlecki</surname>
                            <given-names>M</given-names>
                        </name>

                        <etal/>
</person-group>:
                    <article-title>Comparison of efficacy and safety of lateral-to-medial continuous transversus abdominis plane block with thoracic epidural analgesia in patients undergoing abdominal surgery: A randomised, open-label feasibility study.</article-title>
                    <source>

                        <italic toggle="yes">Eur. J. Anaesthesiol.</italic>
</source>
                    <year>2015 Nov [cited 2023 Oct 26]</year>;<volume>32</volume>(<issue>11</issue>):<fpage>797</fpage>&#x2013;<lpage>804</lpage>.
                    <pub-id pub-id-type="pmid">26426576</pub-id>
                    <pub-id pub-id-type="doi">10.1097/EJA.0000000000000345</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref9">
                <label>9</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>De Cosmo</surname>
                            <given-names>G</given-names>
                        </name>
</person-group>:
                    <article-title>Transversus Abdominis Plane Block: A New Gold Standard for Abdominal Surgery?</article-title>
                    <source>

                        <italic toggle="yes">J. Anesth. Crit. Care Open Access.</italic>
</source>
                    <year>2016 Feb 12 [cited 2022 Sep 1]</year>;<volume>4</volume>(<issue>3</issue>).
                    <pub-id pub-id-type="doi">10.15406/jaccoa.2016.04.00145</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref10">
                <label>10</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Aveline</surname>
                            <given-names>C</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Le Hetet</surname>
                            <given-names>H</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Le Roux</surname>
                            <given-names>A</given-names>
                        </name>

                        <etal/>
</person-group>:
                    <article-title>Comparison between ultrasound-guided transversus abdominis plane and conventional ilioinguinal/iliohypogastric nerve blocks for day-case open inguinal hernia repair.</article-title>
                    <source>

                        <italic toggle="yes">Br. J. Anaesth.</italic>
</source>
                    <year>201 Mar [cited 2023 Oct 26]1</year>;<volume>106</volume>(<issue>3</issue>):<fpage>380</fpage>&#x2013;<lpage>386</lpage>.
                    <pub-id pub-id-type="doi">10.1093/bja/aeq363</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref11">
                <label>11</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Khedkar</surname>
                            <given-names>S</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Bhalerao</surname>
                            <given-names>P</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Yemul-Golhar</surname>
                            <given-names>S</given-names>
                        </name>

                        <etal/>
</person-group>:
                    <article-title>Ultrasound-guided ilioinguinal and iliohypogastric nerve block, a comparison with the conventional technique: An observational study.</article-title>
                    <source>

                        <italic toggle="yes">Saudi J. Anaesth.</italic>
</source>
                    <year>2015 [cited 2023 Oct 26]</year>;<volume>9</volume>(<issue>3</issue>):<fpage>293</fpage>&#x2013;<lpage>297</lpage>.
                    <pub-id pub-id-type="pmid">26240549</pub-id>
                    <pub-id pub-id-type="doi">10.4103/1658-354X.154730</pub-id>
                    <pub-id pub-id-type="pmcid">PMC4478823</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref12">
                <label>12</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Abdelhaq</surname>
                            <given-names>MM</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Adly</surname>
                            <given-names>EM</given-names>
                        </name>
</person-group>:
                    <article-title>Effect of Nalbuphine as Adjuvant to Bupivacaine for Ultrasound-Guided Supraclavicular Brachial Plexus Block.</article-title>
                    <source>

                        <italic toggle="yes">Open J. Anesthesiol.</italic>
</source>
                    <year>2016 [cited 2023 Oct 26]</year>;<volume>06</volume>(<issue>03</issue>):<fpage>20</fpage>&#x2013;<lpage>26</lpage>.
                    <pub-id pub-id-type="doi">10.4236/ojanes.2016.63004</pub-id>
                </mixed-citation>
            </ref>
        </ref-list>
    </back>
    <sub-article article-type="reviewer-report" id="report392566">
        <front-stub>
            <article-id pub-id-type="doi">10.5256/f1000research.158283.r392566</article-id>
            <title-group>
                <article-title>Reviewer response for version 1</article-title>
            </title-group>
            <contrib-group>
                <contrib contrib-type="author">
                    <name>
                        <surname>Tercan</surname>
                        <given-names>Can</given-names>
                    </name>
                    <xref ref-type="aff" rid="r392566a1">1</xref>
                    <role>Referee</role>
                    <uri content-type="orcid">https://orcid.org/0000-0003-1325-6294</uri>
                </contrib>
                <aff id="r392566a1">
                    <label>1</label>Basaksehir Cam and Sakura City Hospital, Istanbul, Turkey</aff>
            </contrib-group>
            <author-notes>
                <fn fn-type="conflict">
                    <p>
                        <bold>Competing interests: </bold>No competing interests were disclosed.</p>
                </fn>
            </author-notes>
            <pub-date pub-type="epub">
                <day>24</day>
                <month>6</month>
                <year>2025</year>
            </pub-date>
            <permissions>
                <copyright-statement>Copyright: &#x00a9; 2025 Tercan C</copyright-statement>
                <copyright-year>2025</copyright-year>
                <license xlink:href="https://creativecommons.org/licenses/by/4.0/">
                    <license-p>This is an open access peer review report distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</license-p>
                </license>
            </permissions>
            <related-article ext-link-type="doi" id="relatedArticleReport392566" related-article-type="peer-reviewed-article" xlink:href="10.12688/f1000research.144479.1"/>
            <custom-meta-group>
                <custom-meta>
                    <meta-name>recommendation</meta-name>
                    <meta-value>approve-with-reservations</meta-value>
                </custom-meta>
            </custom-meta-group>
        </front-stub>
        <body>
            <p>This protocol presents a prospective, randomized study comparing the analgesic efficacy of ultrasound-guided versus anatomical landmark-guided transversus abdominis plane (TAP) blocks in patients undergoing total abdominal hysterectomy under spinal anesthesia. The intervention involves bilateral administration of 0.25% bupivacaine and 10 mg nalbuphine. The primary outcome is the duration of analgesia, while secondary outcomes include block failure rate, time to first rescue analgesia, and adverse effects. The methodology is clearly defined, with appropriate ethical approval and sample size calculation.</p>
            <p> Strengths 
                <list list-type="bullet">
                    <list-item>
                        <p>Clear rationale with clinical relevance, addressing a pertinent question in postoperative analgesia</p>
                    </list-item>
                    <list-item>
                        <p>Well-structured methodology, including ethical approval, randomization, sample size justification, and comprehensive procedural details</p>
                    </list-item>
                    <list-item>
                        <p>Detailed protocol that enhances reproducibility by others, with clearly described intervention arms</p>
                    </list-item>
                    <list-item>
                        <p>The choice of endpoints is clinically meaningful</p>
                    </list-item>
                    <list-item>
                        <p>Appropriate use of VAS scores and sedation scales to quantify outcomes</p>
                    </list-item>
                </list> </p>
            <p> Expanded Context and Clinical Relevance</p>
            <p> The study gains further relevance when considered in the context of differences in postoperative pain between hysterectomy techniques. Total abdominal hysterectomy is associated with significantly more postoperative pain compared to laparoscopic approaches. As recent literature demonstrates, laparoscopic hysterectomy&#x2014;especially using 3D visualization systems&#x2014;offers advantages such as reduced tissue trauma and less need for postoperative analgesia. For example, Tercan et al. (2024) (Ref 1) found that 3D systems in laparoscopic hysterectomy provide improved outcomes regarding pain and recovery compared to traditional 2D systems.</p>
            <p> These findings support the notion that patients undergoing laparotomic hysterectomy face higher analgesic needs, making the optimization of TAP block techniques in this population especially valuable. The current study directly addresses this gap by comparing two TAP block approaches in a high-pain-risk surgical group.</p>
            <p> </p>
            <p> Suggestions for Improvement 
                <list list-type="bullet">
                    <list-item>
                        <p>Clarify the data dissemination plan. While the authors state that results will be presented and published, a formal data availability statement should be included for transparency</p>
                    </list-item>
                    <list-item>
                        <p>Provide a more detailed statistical analysis plan, including which tests will be used for continuous and categorical variables, how assumptions will be tested, and how missing data will be handled</p>
                    </list-item>
                    <list-item>
                        <p>Minor grammatical and phrasing improvements are suggested for clarity and tone. For example, &#x201c;the study will use injections&#x201d; could be revised to &#x201c;the study will administer injections&#x201d;</p>
                    </list-item>
                    <list-item>
                        <p>Include a brief paragraph discussing potential risks of TAP blocks, such as local anesthetic systemic toxicity or bowel injury, and describe how these risks will be managed</p>
                    </list-item>
                    <list-item>
                        <p>Clearly outline how adverse events will be monitored, categorized, and reported throughout the study</p>
                    </list-item>
                    <list-item>
                        <p>Consider briefly discussing in the introduction or discussion that TAP blocks may be particularly important in open abdominal hysterectomies due to the higher postoperative pain burden compared to minimally invasive techniques</p>
                    </list-item>
                </list> </p>
            <p> Conclusion</p>
            <p> This is a clinically relevant and methodologically sound study protocol. With minor revisions related to data sharing, statistical details, and safety monitoring, the study will be well-positioned to contribute meaningfully to the optimization of postoperative pain control in gynecologic surgery.</p>
            <p>Is the study design appropriate for the research question?</p>
            <p>Yes</p>
            <p>Is the rationale for, and objectives of, the study clearly described?</p>
            <p>Yes</p>
            <p>Are sufficient details of the methods provided to allow replication by others?</p>
            <p>Yes</p>
            <p>Are the datasets clearly presented in a useable and accessible format?</p>
            <p>No</p>
            <p>Reviewer Expertise:</p>
            <p>Obstetric and gynecologic surgery, minimally invasive gynecologic techniques</p>
            <p>I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.</p>
        </body>
        <back>
            <ref-list>
                <title>References</title>
                <ref id="rep-ref-392566-1">
                    <label>1</label>
                    <mixed-citation publication-type="journal">
                        <person-group person-group-type="author"/>:
                        <article-title>The comparison of 2D and 3D systems in total laparoscopic hysterectomy: a systematic review and meta-analysis</article-title>.
                        <source>
                            <italic>Archives of Gynecology and Obstetrics</italic>
                        </source>.<year>2024</year>;<volume>310</volume>(<issue>4</issue>) :
                        <elocation-id>10.1007/s00404-024-07630-y</elocation-id>
                        <fpage>1811</fpage>-<lpage>1821</lpage>
                        <pub-id pub-id-type="doi">10.1007/s00404-024-07630-y</pub-id>
                    </mixed-citation>
                </ref>
            </ref-list>
        </back>
    </sub-article>
</article>
