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Study Protocol

Comparison of USG guided with Anatomical Landmark guided TAP Block following Total Abdominal Hysterectomy

[version 1; peer review: 1 approved with reservations]
PUBLISHED 07 Mar 2024
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OPEN PEER REVIEW
REVIEWER STATUS

Abstract

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.

Keywords

Nalbuphine, Transversus Abdominis Plane Block, Anatomical Landmark, Total Abdominal Hysterectomy, Bupivacaine, Subarachnoid Block, Postoperative pain.

Introduction

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.1 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.2

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.3 The duration of postoperative pain relief can be extended by combining local anaesthetics such as bupivacaine with adjuvants like the opioid agonist-antagonist Nalbuphine.4 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.5

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.

Aim

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.

Objectives

  • 1. Primary Objectives

    • To compare the efficacy of USG guided with Anatomical landmark guided TAP block following Total abdominal hysterectomy.

  • 2. Secondary objectives

    • Duration of analgesia with USG guided technique and Anatomical landmark technique,

    • Number of failures of the block with both techniques,

    • Time to administration of rescue analgesia to the patient (VAS>4),

    • Any side effects.

Methods

The research will be conducted in the JNMC Department of Anaesthesiology, Datta Meghe Institute of Higher Education & Research, Sawangi (M), Wardha. The DMIHER Institutional Ethics Committee has granted approval for the research [Ref.No. DMIHER (DU)/IEC/2023/888] on 31st March, 2023. We shall obtain the participants’ signed informed consent before the commencement of the study. A departmental steering group will also supervise and track the study’s advancement until its completion.

Research design – Prospective, comparative design.

Study area – Department of Anaesthesiology JNMC & AVBRH.

Study period – 2 years

Patient allotment – Computer-generated randomization.

Study population – Patients undergoing Total Abdominal Hysterectomy surgeries.

Inclusion criteria

  • - Participants will include females between the ages of 35 and 70,

  • - Patients scheduled to have Total Abdominal Hysterectomy (TAH),

  • - The surgery is expected to take place between one to three hours,

  • - Patients classified as either grade I or II ASA or stage I or II MPC,

  • - Patients who meet the requirements for a Transversus Abdominis Plane (TAP) block,

  • - Patients whose body weight is equal to or more than 50 kg,

  • - Patients indicating a desire to take part in the study.

Exclusion criteria

  • - Lack of a legitimate, documented, and informed consent,

  • - Patients falling into ASA grades III and IV,

  • - Patients weighing less than or equal to 50 kg,

  • - Patients with neurological and musculoskeletal disorders,

  • - Patients with bleeding disorders, patients currently taking anticoagulant medication,

  • - Patients with documented allergies to local anaesthetics and Nalbuphine injections.

Sample size calculation

Formula using Mean difference

n1=n2=2za+zβ2σ2σ2

Zα = 1.96

α = Type 1 error at 5% at both sides two tailed

Zβ = 1.645 = Power at 95%

Primary variable TUG Time to first rescue

Time to first rescue analgesia group 1 Mean Value = 11.87

Time to first rescue analgesia group 2 Mean Value = 9.67

Mean Difference = 2.20 (As Per Reference article)

Standard Deviation = (2.97+ 2.47)/2 = 2.72 (As Per Reference article)

Sample sizeN=n1=n2=21·96+1·6422·7222.202=26per group
Considering 20% drop out=5
Total sample size required26+5=31pergroup.

Reference Article: Kapil Prajapati et al.6

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:

  • Group U – 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).

  • Group A – 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).

Methods

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’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 75–100 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.

  • 1. 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.

  • 2. 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.

In both techniques, the transversus abdominis and rectus abdominis muscles will separate as the drug is administered, allowing the TAP compartment to be dissected.7 Postoperative pain reduction will be achieved with the prompt administration of the TAP Block following the surgical operation.8 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’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’s sedation score will be assessed every ten minutes for a maximum of 180 minutes and whenever the patient feels pain.

Dissemination

The study findings will be displayed at relevant conferences and sent for publication in appropriate journals.

Status of the study

The collection of data is ongoing.

Discussion

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.9 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’ 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—all commonly linked to mu receptor activity. Moreover, neither of the two evaluated procedures indicated dermatomal involvement in our investigation.

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.10 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.11

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.12

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.

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GHOSH A and Ninave DS. Comparison of USG guided with Anatomical Landmark guided TAP Block following Total Abdominal Hysterectomy [version 1; peer review: 1 approved with reservations]. F1000Research 2024, 13:160 (https://doi.org/10.12688/f1000research.144479.1)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions
Version 1
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PUBLISHED 07 Mar 2024
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Reviewer Report 24 Jun 2025
Can Tercan, Basaksehir Cam and Sakura City Hospital, Istanbul, Turkey 
Approved with Reservations
VIEWS 4
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 ... Continue reading
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Tercan C. Reviewer Report For: Comparison of USG guided with Anatomical Landmark guided TAP Block following Total Abdominal Hysterectomy [version 1; peer review: 1 approved with reservations]. F1000Research 2024, 13:160 (https://doi.org/10.5256/f1000research.158283.r392566)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.

Comments on this article Comments (0)

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Comment
Alongside their report, reviewers assign a status to the article:
Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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