[version 1; peer review: 1 approved, 1 approved with reservations]
No competing interests were disclosed.
Spinal anesthesia has a quicker onset of action and completely blocks all motor functions. It requires less local anesthetic and has a reduced rate of failed blocks hence the preferred anesthetic method for lower abdomen procedures is spinal anesthesia. Intrathecal local anesthetics benefit from adjuvant medications by extending postoperative analgesia and thus improving the sensory blockade's duration and quality. Intrathecal opioids and local anesthetics work together synergistically to increase the sensory block while decreasing the sympathetic block. Adjuvants to local anesthetics for intrathecal administration have certain benefits, including lowered local anesthetic medication dose, improved hemodynamic stability, and fewer adverse effects. The opioid medication nalbuphine has a kappa agonist and mu antagonist action that reduces pain without having many negative side effects. It acts on opoid receptor as both an agonist and an antagonist to offer visceral nociception with a moderately powerful analgesic. Almost all general anesthesia and regional anesthesia treatments employ it. To cause analgesia, nalbuphine adheres to k receptors. Perioperative analgesia is also improved when administered as an adjuvant to bupivacaine. It is a hybrid which has both agonist and antagonist actions that increases and attenuates the effects of opioids. Numerous researchers have investigated the properties of intrathecal nalbuphine. This study's objective to determine the efficacy of injectable nalbuphine as an augmentation to intrathecal bupivacaine in endoscopic urological surgeries to extend post operative analgesia.
Lower abdomen and lower leg procedures frequently use the anesthetic approach known as a subarachnoid blockade. The quality and length of the sensory blockage are improved by intrathecal local anesthetics combined with adjuvant medicines, which also prolong postoperative analgesia. The most often used spinal adjuvants to extend postsurgical analgesia are intrathecal opioids.
To induce moderately effective analgesia of visceral nociception, nalbuphine, a synthetic opioid analgesic that is extremely lipid-soluble, acts as both an agonist and an antagonist at the -opioid receptor.
Nalbuphine can counteract the negative effects of spinal opiates because, when administered systemically, it has a less rate of causing depression in respiratory system.
This investigation compares the effectiveness of intrathecal injections of bupivacaine and nalbuphine for the analgesic effects during endoscopic urological procedures. The duration of analgesia will be the main result. Secondary outcomes include 2 dermatome regression, motor block duration, the cephalic extension, changes in hemodynamic parameters, and occurrence of side effects for example shivering, itching, fatigue, nausea/vomiting, and respiratory depression.
To compare the efficacy of the addition of Intrathecal Injection Nalbuphine as an adjuvant to Bupivacaine with Intrathecal Injection Bupivacaine alone for analgesia in endoscopic urological surgeries.
To compare the duration of postoperative analgesia between Intrathecal Bupivacaine alone and with Injection Nalbuphine as an adjuvant to Injection Bupivacaine.
To compare the effect on hemodynamic parameters. The commence and duration of sensory and motor block. Adverse consequences (sedation degree, postoperative nausea, vomiting, shivering, urinary retention, and any other)
After receiving approval from the Datta Meghe Institute of Education & Research, Sawangi (M), Wardha, DMIMS Institutional Ethical Committee and Screening Committee, the study will be carried out in the Department of Anaesthesiology, JNMC. Before the procedure, written and informed consent will be taken from the participants. Departmental steering committee will be monitoring the progress of study till completion.
Research design: Comparative Prospective
Study area: Department of Anaesthesiology JNMC & AVBRH.
Study period: 2 years
Study population: Patients undergoing Urological surgeries.
Allocation of patient: Computer generated randomization.
Males and females between the age group of 25-70 years
Patient undergoing Urological operations.
Duration of Surge 1-3 hours
ASA I & II
MPC I & II
Patients willing to participate in the study
Patient fulfilling criteria for subarachnoid block
Lacking valid informed and written consent
Patients with a history of bleeding disorders
ASA grade III and IV
Localized Infection at the block site
Patient currently on anticoagulants
Patients who have a history of neurological and musculoskeletal disease
The study will involve 60 participants who meet all inclusion requirements.
Two study groups will be randomly selected among the study's participants (
Group A (n = 30): Injection Bupivacaine 15 mg (3 ml) + Sterile NS 0.2 ml
Group B (n = 30): Injection Bupivacaine 15 mg (3 ml) + Injection Nalbhuphine 1.5 mg (0.2 ml)
| Group | Drug given | Total volume |
|---|---|---|
| B | Injection Bupivacaine 0.5% heavy 3 ml (15 mg) + 0.2 ml NS | 3.2 ml |
| BN | Injection Bupivacaine 0.5% heavy 3 ml (15 mg) plus, Injection of Nalbuphine 0.2 ml (1.5 mg) (Preservative free) | 3.2 ml |
Statistical analysis will be done using SPSS version 15.0 and a graphical representation of a mean P value of < 0.05 will be considered significant.
The calculation of sample size is based on:
Sample size formula for difference between two means
Where
Zα is the level of significance at 5% i.e., 95% confi1dence interval = 1.96
Zβ is the power of the test = 80% = 0.84
σ 1 = SD of onset of sensory block in group C = 1.05
σ 2 = SD of onset of sensory block in group M = 0.44
Δ = 3.04 – 1.95 = 0.61 and k = 1
n = 30
Reference = VK Chandra sample size determination in health studies, NTI Bulletin, 2006, 42/3 and 4, 55-62.
I. A Day before the surgery, all patients will go through a pre anesthesia check-up.
ii. Basic patient information, including demographics, the illness's history, and current manifestations, a general examination, comprehensive evaluation, blood tests, and lab work will be indicated
iii) Aim, benefits, and drawbacks will be informed to the patients
iv) Each patient who will be a part of the study will give their informed, written consent.
v) They will be required to continue fasting for at least eight hours before the procedure.
v. The study's participants will be split into two groups at random (
Group A (n = 30): Injection Bupivacaine 15 mg (3 ml) + Sterile NS 0.2 ml
Group B (n = 30): Injection Bupivacaine 15 mg (3ml) + Injection Nalbhuphine 1.5 mg (0.2 ml)
An ECG, pressure monitor, and spo2 probe will be attached intraoperatively. 18g iv cannula will be used to secure an IV line, and fluid @ 10- to 15 ml/kg of Ringer Lactate will be given. Baseline vitals: Lead II's electrocardiogram will be continuously shown, Oxygen saturation, blood pressure, and heart rate will also be recorded for the patient. Premedication will be administered to all patients. 10 minutes before the anesthesia procedure, provide ondansetron 75–100 mcg/kg intravenously. Subarachnoid block using 25-gauge Quinke’s needle with the patient seated or leaning to the left in L3-4/L4-5 intervertebral area in midline will be given
The patient will be promptly turned into the supine position after the surgery is finished.
Oxygen will be given as a supplement to all patients (4-6 litres per minute via Hudson’s mask).
Upcoming values will be noted.
The motor and sensory paralysis onset. Highest level of sensory blocking that is reached and the length of time it takes to reach that level will be reported. The sensory blockade's two-segment regression time Sedation level VAS postoperative pain evaluation When to use rescue analgesia Negative outcomes, if any.
Until surgical anesthesia is obtained at dermatome level T10, the sensory blockage will be assessed using a blunt-tipped needle every 2 minutes. The motor block will be evaluated with modified Bromage scale.
The method entails checking parameters, two minutes for the first ten minutes, then the next 30 minutes every five minutes, and then every 15 minutes for the remaining time. If the heart rate falls below 20% of baseline Inj. Glycopyrrolate 0.2 mg will be administered In case there is hypotension (below 20% of baseline) Inj. Mephentermine in titrated boluses will be administered. After the study drug is administered, any adverse effects will be recognized and dealt with accordingly. Symptoms such as vomiting, shivering, nausea, and pruritus, will be recorded. Ondansetron 4 mg i/v for nausea and vomiting,
Inj Tramadol 50 mg i/v for shivering, Inj Hydrocortisone 100mg and injection Pheniramine Maleate for pruritus or any allergic reactions
The patients will be shifted to the monitoring ward. They will be monitored every 30 minutes for the first 6 hours and thereafter for 24 hours. Rescue analgesia will be given with iv paracetamol will be administered (15-20 mg/kg) when VAS is 4 or more.
At one-minute intervals, the progression of the block was assessed until it reached the T6. The sensory block will be measured using the pinprick method in the midclavicular line with a 27 G needle. The level was then tested every two minutes until the maximum sensory block was reached.
When the highest degree of the sensory blockade has decreased by two segments after the injection of local anesthetic solution, the duration of the sensory blockade will be measured using TWO SEGMENT REGRESSION.
Bromage scale was used to ascess motor block.
The duration between the administration of the study medication and the point at which the Bromage 3 was detected is known as the onset of total motor blockage.
When total anesthesia is established, surgery can begin. Both the sensory and motor levels will be assessed following surgery. Regression to level L1 and two-segment regression time from the maximum level will also be noted. Patients will be routinely monitored in the recovery and postoperative ward following surgery to assess their level of pain using the VAS scale
According to the study, which investigated the efficacy of intrathecal nalbuphine, the medication was found to elevate the potency of SAB and provided better pain control without affecting the patients' hemodynamic profile. Effective analgesia was measured as the time from injection to visual analog scale (VAS) score less than three. No cases of respiratory depression, sedation nausea, pruritus or vomiting were observed. They are typically associated with the activity of the μ receptor, as indicated by past research.
Comparisons have been made between nalbuphine and other spinal adjuvants that are frequently used, such as morphine and fentanyl. Study on patients undergoing cesarean section and found that compared to nalbuphine as an intrathecal adjuvant, morphine resulted in a longer duration of analgesia but also led to an adverse consequences such as pruritus, nausea, and vomiting in few cases.
Evaluation of Nalbuphine as an Intrathecal Adjuvant to 0.5% Hyperbaric Bupivacaine at Two Different Doses for Postoperative Pain Management Following Abdominal Hysterectomy it was determined that heavy bupivacaine for sub arachnoid block works well when combined with 1.6 mg of intrathecal nalbuphine. While having no impact on breathing, it potentiated the SAB features and extended the analgesic effect. Nalbuphine with a dosage of 2.4 mg had no further benefits.
Following tubeless percutaneous nephrolithotomy, It was found that caudal bupivacaine can lower the severity of bladder discomfort caused by catheter both by itself and when combined with adjuvant fentanyl and nalbuphine.
In our investigation, we anticipate that Group BN and Group B experience motor blockades for roughly the same amount of time. Better intra operative anesthetic quality is anticipated in Group BN. Additionally, we anticipate that Group BN will experience longer full and effective analgesia than Group B.
Control group data collection ongoing.
According to the study, which investigated the efficacy of intrathecal nalbuphine, the medication was found to elevate the potency of SAB and provided better pain control without affecting the patients' hemodynamic profile. Effective analgesia was measured as the time from injection to visual analog scale (VAS) score less than three. No cases of respiratory depression, sedation nausea, pruritus or vomiting were observed. They are typically associated with the activity of the μ receptor, as indicated by past research.
Comparisons have been made between nalbuphine and other spinal adjuvants that are frequently used, such as morphine and fentanyl. Study on patients undergoing cesarean section and found that compared to nalbuphine as an intrathecal adjuvant, morphine resulted in a longer duration of analgesia but also led to an adverse consequences such as pruritus, nausea, and vomiting in few cases.
Evaluation of Nalbuphine as an Intrathecal Adjuvant to 0.5% Hyperbaric Bupivacaine at Two Different Doses for Postoperative Pain Management Following Abdominal Hysterectomy it was determined that heavy bupivacaine for sub arachnoid block works well when combined with 1.6 mg of intrathecal nalbuphine. While having no impact on breathing, it potentiated the SAB features and extended the analgesic effect. Nalbuphine with a dosage of 2.4 mg had no further benefits.
Comparing the duration of the sensory block in the buprenorphine group to that in the nalbuphine group after using intrathecal nalbuphine and buprenorphine as an adjuvant in lower limb orthopaedic procedures. But throughout the whole intraoperative and postoperative time, neither group's blood pressure nor heart rate significantly decreased.
INSTITUTIONAL ETHICS committee approved research to be carried out at JAWAHARLAL NEHRU MEDICAL COLLEGE, SAWANGI. Reference number DMIMS (DU)/II/C/2022/93.
No data are associated with this article.
The author would like to acknowledge the support from staff of Department of Anaesthesia, JNMC, AVBRH, Sawangi, Wardha, India.
Is the study design appropriate for the research question?
Yes
Is the rationale for, and objectives of, the study clearly described?
Yes
Are sufficient details of the methods provided to allow replication by others?
Yes
Are the datasets clearly presented in a useable and accessible format?
Yes
Reviewer Expertise:
NA
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.
I acknowledge the authors efforts in conducting this trial which evaluates the effectiveness of nalbuphine as a spinal anesthesia additive to prolong the duration of postoperative analgesia and decrease the incidence of side effects in comparison to Bupivacaine alone. However, I have the following major concerns regarding the study construction;
First, The manuscript needs thorough revision before further processing regarding language and grammar, as the authors used three verb tenses (past, present, and future) while describing the study methods.
The abstract is not well-structured and doesn't reflect the main features of the study methods, results, and conclusion. It is more like a summary of the introduction.
The introduction needs more concentration on the importance of your work and how it was different from the other literature that investigated similar research point.
The sample size was not properly calculated. The sample size should be calculated based upon the study 1ry outcome ( duration of analgesia) not onset of sensory block. There was no reference for the prior estimate, also it is improper to use equations anymore in presence of many software that could calculate it more accurately. I think the study was underpowered by the sample size.
The study design was not described appropriately as a randomized clinical trial and didn't mention if it was blinded or not.
The methods were not clear enough starting from the method of randomization and allocation, the authors need to clarify who was responsible for the process of allocation, anesthesia administration, and outcome collection. Also, The outcomes were not described clearly, for example, What did you mean by duration of analgesia ( the study 1ry outcome) was it the sensory duration of the block or analgesia time or effective analgesia time, define the start and end time points accurately. The hemodynamics were included in your secondary outcomes, however they were not described in the methodology or results.
authors should declare The brand name of used nalbuphine and if it was preservative free.
The statistical analysis was not sufficiently described.
No results section.
The discussion section should be rewritten, 1st para of discussion shall be the summary of your key findings, and subsequent paragraphs should be the comparison of your findings with those of previous studies, Last paragraph shall include limitations of your study and then the conclusion ... The previous literature, authors cited in the discussion, should focus on similar study designs with similar conditions as theirs, for example, the present study didn’t include other additives than nalbuphine to hold a comparison with nor include open urological surgeries ( percutaneous nephrolithotomy) to cite its results.
Is the study design appropriate for the research question?
Partly
Is the rationale for, and objectives of, the study clearly described?
Partly
Are sufficient details of the methods provided to allow replication by others?
No
Are the datasets clearly presented in a useable and accessible format?
No
Reviewer Expertise:
anesthesiology, pain management, and intensive care.
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.