Randomised control trial comparing postoperative analgesia between nalbuphine and fentanyl as an adjuvant with intrathecal levobupivacaine for lower abdominal gynaecological surgeries

SAELY PAUNIKAR; Dr. Sanjot Ninave

doi:10.12688/f1000research.144559.1

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Study Protocol

Randomised control trial comparing postoperative analgesia between nalbuphine and fentanyl as an adjuvant with intrathecal levobupivacaine for lower abdominal gynaecological surgeries

[version 1; peer review: 2 approved with reservations]

SAELY PAUNIKAR ¹, Dr. Sanjot Ninave¹

PUBLISHED 23 Apr 2024

Author details Author details

¹ ANAESTHESIOLOGY, DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH, WARDHA, MAAHARSHTRA, 442001, India

SAELY PAUNIKAR
Roles: Conceptualization, Writing – Original Draft Preparation, Writing – Review & Editing

Dr. Sanjot Ninave
Roles: Supervision

OPEN PEER REVIEW

REVIEWER STATUS

This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

Background

Effective post-operative pain management is crucial for patient comfort and recovery following lower abdominal gynaecological surgeries. This study protocol outlines a randomised control trial designed to compare the efficacy and safety of two intrathecal adjuvants, nalbuphine and fentanyl, in conjunction with hyperbaric levobupivacaine for postoperative analgesia.

Methods

The study will be conducted at the Department of Anaesthesiology, Jawaharlal Nehru Medical College, DMIMS (DU), and affiliated institutions. Sixty eligible patients aged 35-75 years undergoing lower abdominal gynaecological surgeries under subarachnoid block will be randomly assigned to one of two groups. Group A will receive nalbuphine with levobupivacaine, while Group B will receive fentanyl with levobupivacaine. Patients will be monitored for the duration of post-operative analgesia, onset of sensory and motor block, hemodynamic effects, and side effects.

Outcomes

The primary outcome is the comparison of post-operative analgesia duration between nalbuphine and fentanyl. Secondary outcomes include assessing sensory and motor block onset, hemodynamic changes, ephedrine usage, and side effects.

Aim

To evaluate the efficacy and safety of intrathecal nalbuphine and fentanyl as adjuvants with hyperbaric levobupivacaine for postoperative analgesia in lower abdominal gynaecological surgeries.

Keywords

Intrathecal, Nalbuphine, Fentanyl, Levobupivacaine, Gynecological surgeries, postoperative analgesia

Corresponding author: SAELY PAUNIKAR

Competing interests: No competing interests were disclosed.

Grant information: The author(s) declared that no grants were involved in supporting this work.

Copyright: © 2024 PAUNIKAR S and Ninave DS. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: PAUNIKAR S and Ninave DS. Randomised control trial comparing postoperative analgesia between nalbuphine and fentanyl as an adjuvant with intrathecal levobupivacaine for lower abdominal gynaecological surgeries [version 1; peer review: 2 approved with reservations]. F1000Research 2024, 13:347 (https://doi.org/10.12688/f1000research.144559.1) First published: 23 Apr 2024, 13:347 (https://doi.org/10.12688/f1000research.144559.1) Latest published: 23 Apr 2024, 13:347 (https://doi.org/10.12688/f1000research.144559.1)

Introduction

Effective post-operative pain management is a cornerstone of modern healthcare, as it directly influences patient comfort, recovery, and overall satisfaction with medical interventions. Lower abdominal gynaecological surgeries, including procedures such as hysterectomies and ovarian surgeries, often present unique challenges in the context of pain management. Patients undergoing these surgeries require a balance between adequate postoperative analgesia and minimising adverse effects to facilitate a smooth recovery process.¹

Intrathecal anaesthesia, particularly when combined with adjuvants, is a well-established method for managing perioperative pain in lower abdominal surgeries.² The choice of adjuvant, however, can significantly impact the quality and duration of post-operative pain relief. Nalbuphine and fentanyl are two commonly employed adjuvants, each with distinct pharmacological properties and potential advantages in this context.³

Nalbuphine, a synthetic opioid, exhibits mixed agonist-antagonist properties at opioid receptors, which may provide potent analgesia while minimising the risk of respiratory depression and other opioid-related side effects.⁴ Fentanyl, a highly potent opioid, offers rapid onset and profound analgesic effects but may be associated with a higher risk of certain adverse events. Therefore, selecting the optimal intrathecal adjuvant is a critical consideration for healthcare providers.⁵

This study protocol outlines a randomised control trial designed to compare the efficacy and safety of intrathecal nalbuphine and fentanyl when used as adjuvants with hyperbaric levobupivacaine for postoperative analgesia in lower abdominal gynaecological surgeries. The primary objective is to assess the duration of post-operative analgesia. At the same time, secondary outcomes include the onset of sensory and motor block, hemodynamic effects, ephedrine usage, and the incidence of side effects. The results of this study are anticipated to provide valuable insights into the optimal choice of intrathecal adjuvants for pain management in lower abdominal gynaecological surgeries. By enhancing our understanding of the benefits and potential risks associated with nalbuphine and fentanyl, this research may improve clinical practice and patient outcomes in this specific surgical population.

Primary objective

1. To compare the duration of postoperative analgesia between intrathecal nalbuphine and intrathecal fentanyl when administered as adjuvants with hyperbaric levobupivacaine in lower abdominal gynaecological surgeries.

Secondary objectives

1. To compare the onset of the sensory and motor block between intrathecal nalbuphine and intrathecal fentanyl in conjunction with hyperbaric levobupivacaine.
2. To assess the impact of intrathecal nalbuphine and intrathecal fentanyl on hemodynamic parameters during lower abdominal gynaecological surgeries and the requirement for ephedrine to manage hypotension.
3. To evaluate and compare any potential side effects associated with the use of intrathecal nalbuphine and intrathecal fentanyl in combination with hyperbaric levobupivacaine for postoperative analgesia.

Methods

Study setting: The study will be conducted at the Department of Anaesthesiology at Jawaharlal Nehru Medical College, DMIMS (DU), Acharya Vinoba Bhave Rural Hospital (AVBRH), and Datta Meghe Institute of Medical Sciences, Sawangi (M), Wardha.

Inclusion criteria

1. Patients aged between 35-75 years old.
2. Patients scheduled for lower abdominal gynaecological surgeries under subarachnoid block.
3. The duration of surgery is expected to be at most 120 minutes.
4. Patients classified under the American Society of Anesthesiologists (ASA) as class I or II.
5. Patients with Mallampati classification I or II.
6. Patients who willingly provide informed written consent to participate in the study.

Exclusion criteria

1. Patients who do not provide valid informed written consent.
2. Patients with ASA grades III and IV.
3. Patients with active infection at the injection site for subarachnoid block.
4. Patients diagnosed with significant neurological and musculoskeletal diseases.
5. Patients with known bleeding disorders.
6. Patients who are taking anticoagulants.
7. Patients with a documented history of allergy to local anaesthetics, fentanyl, and nalbuphine.

Interventions

This study will include two groups:

Group A: Participants in this group will receive the following intrathecal medication:

• Inj. Levobupivacaine 3 ml (15 mg) of 0.5%.
• Nalbuphine 0.1 ml (1 mg).
• 0.4 ml of normal saline.

Group B: Participants in this group will receive the following intrathecal medication:

• Inj. Levobupivacaine 3 ml (15 mg) of 0.5%.
• Fentanyl 0.5 ml (25 mcg).

Patients in both groups will undergo spinal anaesthesia after a thorough pre-anaesthetic checkup and confirmation of their vital parameters before the start of surgery Table 1. Patients who experience failed spinal anaesthesia or require additional interventions will be excluded from the study.

Table 1. Doses for the two groups.

Group	Drug given	Total volume
A	Levobupivacaine 3 ml (15 mg) of 0.5% + Nalbuphine 0.1 ml (1 mg) + 0.4 ml normal saline	3.5 ml
B	Levobupivacaine 3 ml (15 mg) of 0.5% + fentanyl 0.5 ml (25 mcg)	3.5 ml

The primary difference between the two groups lies in the adjuvants administered intrathecally - Group A receiving nalbuphine and Group B receiving fentanyl in conjunction with levobupivacaine. The study will assess the impact of these different adjuvants on postoperative analgesia and related parameters.

Outcomes

Primary outcome:

1. The primary objective of this study is to compare the duration of postoperative analgesia between intrathecal nalbuphine and intrathecal fentanyl when administered as adjuvants with hyperbaric levobupivacaine for lower abdominal gynaecological surgeries. The primary outcome will be assessed by measuring the time from the end of surgery to the first request for analgesia by the patient.

Secondary outcomes:

1. Onset of sensory and motor block: The time to onset of sensory and motor block will be compared between the nalbuphine and fentanyl groups. Sensory block onset will be determined by assessing the interval between the injection of the local anaesthetic drug and the loss of sensation to a pinprick at a predetermined dermatomal level. Motor block onset will be assessed using a modified Bromage scale.
2. Hemodynamic effects and ephedrine usage: The study will evaluate the impact of intrathecal nalbuphine and intrathecal fentanyl on hemodynamic parameters during lower abdominal gynaecological surgeries. The requirement for intravenous ephedrine to manage hypotension, defined as a systolic blood pressure less than 90 mm Hg or a drop of more than 20% from baseline, will be recorded.
3. Side-effects: Any potential side effects associated with the use of intrathecal nalbuphine and intrathecal fentanyl in combination with hyperbaric levobupivacaine will be documented and compared. This includes adverse events such as nausea, vomiting, pruritus, and respiratory depression.

Recruitment

To achieve the target sample size of 60 patients who meet the inclusion criteria, the following recruitment process will be followed:

1. Patient counseling and explanation: Potential study participants will be identified during the pre-anesthetic check-up. Patients will be thoroughly counselled and explained the study’s purpose, procedures, and potential benefits. They will be informed about the need for the study and the expected outcomes, particularly the potential for enhanced intraoperative and postoperative pain relief with either nalbuphine or fentanyl as adjuvants in their spinal anaesthesia.
2. Informed consent: Patients who express their willingness to participate in the study will receive a detailed informed consent form. The form will outline the study’s objectives, procedures, potential risks, and benefits. Patients can ask questions and clarify any concerns they may have. Those who provide valid informed written consent will be enrolled in the study.
3. Patient selection: Patients recruited for the study will meet all the inclusion criteria, ensuring they fall within the specified age range, require lower abdominal gynaecological surgeries under the subarachnoid block, and meet the specified ASA and Mallampati classifications.
4. Preoperative evaluation: Each recruited patient will undergo a thorough preoperative evaluation the day before surgery to assess their overall fitness. This evaluation will include various measurements and tests, as outlined in the protocol.
5. Randomization: Patients will be randomly assigned to one of the two study groups, Group A (nalbuphine) or Group B (fentanyl), using a predetermined randomisation method, such as computer-generated random numbers. Randomisation will be conducted by personnel not directly involved in the study to ensure unbiased allocation.
6. Blinding: Patients and the anesthesiologist responsible for recording perioperative data will be blinded to the study drug assignment. This double-masked approach will ensure that the patients and the medical personnel know the administered drug at the end of the study.

Sample size

The research will be conducted on 60 patients who meet all the inclusion criteria and provide informed written consent to participate. These patients will be divided into two study groups: Group A (n=30), which will receive nalbuphine with levobupivacaine, and Group B (n=30), which will receive fentanyl with levobupivacaine.

Justification of sample size

The sample size calculation is based on the formula for the difference between two means:

n = {(Zα + Zβ)}^{2} [{σ 1}^{2} + {σ 2}^{2} / k] / Δ^2

Where:

• Zα is the level of significance at 5% (95% confidence interval) = 1.96.
• Zβ is the power of the test = 80% = 0.84.
• σ1 is the standard deviation of the onset of sensory block in Group C = 1.05.
• σ2 is the standard deviation of the onset of sensory block in Group M = 0.44.
• Δ is the difference in the means of the two groups (3.04-1.95 = 0.61), and k is set to 1.

Plugging these values into the formula:

n = {(1.96 + 0.84)}^{2} [{1.05}^{2} + {0.44}^{2} / 1] / {0.61}^{2}

n ≈ 30 patients needed in each group (Reference study⁶)

Allocation

1. The allocation of patients into the two study groups, Group A and Group B, will be done using a randomisation process. A predetermined randomisation method, such as computer-generated random numbers or randomisation software R studio Version 4.3.1, will ensure that the allocation is unbiased and not influenced by the researchers or healthcare providers.

Blinding

1. This study will be conducted as a double-blind trial. Double blinding means that the patients and the medical personnel involved in the study will be blinded to the drugs administered. The blinding ensures that neither the patients nor the healthcare providers are aware of whether the patient is receiving nalbuphine or fentanyl with levobupivacaine.
2. To maintain blinding, the study conductors and anesthesiologists responsible for patient care will only know about the study drug administered at the end of the study. The actual drugs (nalbuphine or fentanyl) will be concealed, and the patients will not be informed about which drug they are receiving.
3. Blinding is essential to eliminate potential biases and ensure that the patients’ or healthcare providers’ expectations or beliefs do not influence the study results. Blinding is a crucial method to maintain the integrity of the research and reduce the risk of bias in the study’s outcomes.

Data collection process

1. Preoperative data collection: Before surgery, preoperative data will be collected, including demographic information, patient history, and clinical assessments. This may include age, sex, medical history, ASA classification, and Mallampati classification.
2. Randomization and blinding: Patients will be randomly assigned to either Group A (nalbuphine with levobupivacaine) or Group B (fentanyl with levobupivacaine) using a predetermined randomisation method. The allocation will be concealed to maintain double-blinding.
3. Intraoperative monitoring: Patients will be continuously monitored for hemodynamic parameters during the surgery, including peripheral oxygen saturation, non-invasive blood pressure, and pulse rate. Data will be recorded at regular intervals throughout the procedure.
4. Onset of sensory and motor block: The time to onset of sensory and motor blocks will be recorded. Sensory block onset will be determined by assessing the interval between the injection of the local anaesthetic drug and the loss of sensation to a pinprick at a predetermined dermatomal level. Motor block onset will be assessed using a modified Bromage scale.
5. Hemodynamic changes and medication use: Any hemodynamic changes, such as hypotension (systolic blood pressure < 90 mm Hg) or bradycardia (heart rate < 50 beats/min), will be documented. In cases of hypotension, intravenous ephedrine (5-10 mg) will be recorded. For bradycardia, the administration of intravenous atropine (0.6 mg) will be documented.
6. Sedation assessment: Intraoperative sedation levels will be assessed using the Ramsey Sedation Score at baseline (before the subarachnoid block), post-op before shifting to the Post Anesthesia Care Unit, and at the time of the first complaint of pain.
7. Postoperative data collection: In the recovery and postoperative ward, patients will be routinely followed up for pain assessment using the Visual Analogue Scale (VAS). Patients will be educated about the VAS scale, and their pain scores will be assessed regularly.
8. Assessment of primary and secondary outcomes: The primary outcome, the duration of postoperative analgesia, will be assessed by measuring the time from the end of surgery to the first request for analgesia by the patient. The secondary outcomes will also be assessed and recorded, including sensory and motor block characteristics, hemodynamic changes, ephedrine usage, and side effects.
9. Data monitoring: Data will be monitored by a resident doctor not involved in the study. They will ensure the accurate collection and recording of data as per the study protocol.
10. Data management: Collected data will be stored and managed according to standard research and data management practices, ensuring data integrity and confidentiality.

Ethical considerations

This study has been approved by the Datta Meghe Institute of Higher Education and Research (approval number: DMIMS (DU)/IEC/2022/94; approval date: 20/07/2022). CTRI (REF/2023/06/06827; 13/06/2023).

Dissemination

After the completion of the study, we will publish it in an indexed journal or conference.

Study status

The study has yet to start. After the publication of the protocol, we will start recruitment in the study.

Discussion

Intrathecal anaesthesia has become an indispensable tool in the armamentarium of anesthesiologists, offering precise and efficient pain management for various surgical procedures, including lower abdominal gynaecological surgeries. The choice of intrathecal adjuvants plays a pivotal role in determining the quality and duration of postoperative analgesia while managing the risks associated with opioid use. The present study is designed to investigate the comparative efficacy of two intrathecal adjuvants, nalbuphine and fentanyl, in combination with hyperbaric levobupivacaine for postoperative pain control.

One of the primary objectives of this study is to assess the duration of postoperative analgesia achieved with intrathecal nalbuphine and fentanyl. Extending the duration of effective pain relief is crucial for patient comfort and recovery. In a study by Arghya Mukherjee et al., intrathecal nalbuphine demonstrated a significantly longer duration of postoperative analgesia compared to intrathecal fentanyl in orthopaedic surgery patients.⁷ Our study aims to evaluate whether similar results can be observed in the context of lower abdominal gynaecological surgeries.

Another critical aspect of intrathecal anaesthesia is sensory and motor block onset. The rapidity with which the block is achieved impacts the overall quality of the anaesthetic technique. In a study by Biswas et al., nalbuphine was shown to produce a faster onset of sensory block compared to fentanyl when used as an adjuvant to intrathecal hyperbaric bupivacaine in urological surgeries.⁸ Our study will investigate whether the same trend is observed in the context of gynaecological surgeries.

Hemodynamic stability during surgery is of paramount importance. The choice of intrathecal adjuvant can influence the incidence of hypotension and bradycardia. A study by Mahnaz S Shah et al. found that nalbuphine, when used as an adjuvant to intrathecal bupivacaine, resulted in significantly less hypotension compared to fentanyl in patients undergoing cesarean sections.⁹ We will closely monitor our study’s hemodynamic parameters and ephedrine use to evaluate any differences.

The incidence of side effects, such as nausea, vomiting, pruritus, and respiratory depression, is a critical consideration when selecting intrathecal adjuvants. With its unique receptor binding profile, Nalbuphine may offer advantages in terms of a lower risk of respiratory depression. However, fentanyl’s rapid onset of action and potent analgesic effects may necessitate a balanced assessment. A comprehensive understanding of the side-effect profiles of these adjuvants is essential to ensure patient safety and satisfaction.¹⁰ This study protocol offers a robust framework for systematically comparing nalbuphine and fentanyl as intrathecal adjuvants in the specific context of lower abdominal gynaecological surgeries. The results of this study are expected to provide valuable insights for clinicians in selecting the most appropriate adjuvant to optimise post-operative pain control while minimising adverse effects.

References

1. Ohnesorge H, Günther V, Grünewald M, et al.: Postoperative pain management in obstetrics and gynecology. J. Turk. Ger. Gynecol Assoc. 2020; 21: 287–297. PubMed Abstract | Publisher Full Text | Free Full Text
2. Khan AL, Singh RB, Tripathi RK, et al.: A comparative study between intrathecal dexmedetomidine and fentanyl as adjuvant to intrathecal bupivacaine in lower abdominal surgeries: A randomized trial. Anesth. Essays Res. 2015; 9: 139–148. PubMed Abstract | Publisher Full Text | Free Full Text
3. Prabhakaraiah UN, Narayanappa AB, Gurulingaswamy S, et al.: “Comparison of Nalbuphine Hydrochloride and Fentanyl as an Adjuvant to Bupivacaine for Spinal Anesthesia in Lower Abdominal Surgeries:” A Randomized, Double-blind Study. Anesth. Essays Res. 2017; 11: 859–863. PubMed Abstract | Publisher Full Text | Free Full Text
4. Edinoff AN, Kaplan LA, Khan S, et al.: Full Opioid Agonists and Tramadol: Pharmacological and Clinical Considerations. Anesthesiol. Pain Med. 2021; 11: e119156. PubMed Abstract | Publisher Full Text | Free Full Text
5. Gupta R, Verma R, Bogra J, et al.: A Comparative study of intrathecal dexmedetomidine and fentanyl as adjuvants to Bupivacaine. J. Anaesthesiol. Clin. Pharmacol. 2011; 27: 339–343. PubMed Abstract | Publisher Full Text | Free Full Text
6. Nazli B, Oguzalp H, Horasanli E, et al.: The Effects on Sensorial Block, Motor Block, and Haemodynamics of Levobupivacaine at Different Temperatures Applied in the Subarachnoid Space. Biomed. Res. Int. 2014; 2014: 132687–132687. PubMed Abstract | Publisher Full Text | Free Full Text
7. Mukherjee A, Pal A, Agrawal J, et al.: Intrathecal nalbuphine as an adjuvant to subarachnoid block: What is the most effective dose? Anesth. Essays Res. 2011; 5: 171–175. PubMed Abstract | Publisher Full Text | Free Full Text
8. Bajwa BS, Singh AP, Rekhi AK: Comparison of intrathecal clonidine and fentanyl in hyperbaric bupivacaine for spinal anesthesia and postoperative analgesia in patients undergoing lower abdominal surgeries. Saudi J. Anaesth. 2017; 11: 37–40. PubMed Abstract | Publisher Full Text | Free Full Text
9. Shah MS, Masoodi T, Hussain SY, et al.: Nalbuphine as an Intrathecal Adjuvant to 0.5% Hyperbaric Bupivacaine in Two Different Doses for Postoperative Analgesia After Abdominal Hysterectomy: A Prospective, Randomized, Double-Blind Control Study. Cureus. 14: e25044. PubMed Abstract | Publisher Full Text | Free Full Text
10. Sharma A, Chaudhary S, Kumar M, et al.: Comparison of nalbuphine versus fentanyl as intrathecal adjuvant to bupivacaine for orthopedic surgeries: A randomized controlled double-blind trial. J. Anaesthesiol. Clin. Pharmacol. 2021; 37: 529–536. PubMed Abstract | Publisher Full Text | Free Full Text

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Author details Author details

¹ ANAESTHESIOLOGY, DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH, WARDHA, MAAHARSHTRA, 442001, India

SAELY PAUNIKAR
Roles: Conceptualization, Writing – Original Draft Preparation, Writing – Review & Editing

Dr. Sanjot Ninave
Roles: Supervision

Competing interests

No competing interests were disclosed.

Grant information

The author(s) declared that no grants were involved in supporting this work.

Article Versions (1)

version 1

Published: 23 Apr 2024, 13:347

https://doi.org/10.12688/f1000research.144559.1

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© 2024 PAUNIKAR S and Ninave DS. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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PAUNIKAR S and Ninave DS. Randomised control trial comparing postoperative analgesia between nalbuphine and fentanyl as an adjuvant with intrathecal levobupivacaine for lower abdominal gynaecological surgeries [version 1; peer review: 2 approved with reservations]. F1000Research 2024, 13:347 (https://doi.org/10.12688/f1000research.144559.1)

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Reviewer Report 29 Aug 2024

Samar Rafik Amin, Benha University, Benha, Egypt

Approved with Reservations

https://doi.org/10.5256/f1000research.158372.r314397

This protocol was proposed for conducting a comparative study between fentanyl and nalbuphine as adjuvant to local anesthetics during the subarachnoid block for lower abdominal gynecological surgeries based on randomized study design. the protocol is well written, however i have ... Continue reading

This protocol was proposed for conducting a comparative study between fentanyl and nalbuphine as adjuvant to local anesthetics during the subarachnoid block for lower abdominal gynecological surgeries based on randomized study design. the protocol is well written, however i have the following concerns:

1- Title includes the description as randomized controlled trial, but no control group in the methods. two active comparators will be compared without control group!
It is better to identify the type of operation as open not laparoscopic.

2- In the abstract :
Move the aim paragraph at the end of the background and the no need for outcomes paragraph separated from the methods. also, write the study design and duration in the methods

3- The introduction is where you build your hypothesis based on the previous literature. the study point of search has been utilized in many researches before ( fentanyl versus nalbuphine as local anesthetic adjuvants so, what are the conflicts or issues regarding previous reports , your study will try to resolve? clear this point in your hypothesis in the introduction.
Also, avoid repetition of your objectives many times .. enumerate them briefly in your study objectives then mention their details in the methods

4- Methods:
Add the anticipated study duration time.
Clarify the procedure as open not laparoscopic in the inclusion criteria
Mention the dermatomal level that will be established as onset level, and the bromage score that will be considered as onset of motor block.
Define the type of hemodynamic parameters (MAP -SBP- DBP- HR- CVP ... etc) that will be measured and the time points of measurements
define the duration time for Side effects follow up.

5- In sample size calculation: what is group C and group M ..
Please add the reference from which you obtained the mean and SD of the onset of sensory block. Additionally, sample size should be calculated based on the study 1ry outcome (duration of analgesia) not the 2ry outcome

Also, add a section to define the statistical analysis method.

6- Allocation concealment is a process of concealing the allocation sequence from the investigator responsible for recruiting patients, it is different from randomization.
Some standard methods of ensuring allocation concealment include sequentially numbered, opaque, sealed envelopes (SNOSE); sequentially numbered containers; pharmacy controlled randomization; and central randomization.

7- Define who will perform the block and the operation .. the same team or different ones ?

8- There is a discrepancy between the parameters that were mentioned in the measured outcomes and the collected data as you add the sedation score and the VAS score .. please unify your intended outcomes.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Yes

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Anaesthesia, pain therapy, perioperative medicine, 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.

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Reviewer Report 24 Jun 2024

Philippe Richebe, University of Montreal, Montreal, Canada

Approved with Reservations

https://doi.org/10.5256/f1000research.158372.r288368

This is a study protocol proposed here.
Lower abdominal gynaecological surgeries could be more precise and better describe to avoid biases due to too many different types of approach which lead to different type and

This is a study protocol proposed here.
Lower abdominal gynaecological surgeries could be more precise and better describe to avoid biases due to too many different types of approach which lead to different type and level of postoperative pain. Please avoid too much heterogeneity.
Nalbuphine and fentanyl will be added to the intrathecal injection of hyperbaric levobupivacaine. Intraoperative pain assessments and patients’ satisfaction could also be reported, not only intraoperative side effects or postoperative outcomes.
Primary outcome is duration of postoperative analgesia. This could be more precisely described. A better definition is warranted: time for 1^st need or requirement of analgesics? Time for the pain level to reach a certain threshold? … Please provide a clear and precise definition, also in the abstract.
Impact on hemodynamic parameters: the same protocol for blood pressure management as well as fluid loading must be respected and described precisely, so there is no bias due to heterogeneity in hypovolemia prior or during the anesthesia.
The procedure of blinding for the anesthesiologist and the research team who will follow-up on the patients must be clearly stated.
Power calculation: it seems that the power calculation was made using “onset of the sensory block”, but the primary objective of the study is not this outcome. The primary outcome is Time for requirement of analgesia. Power calculation must be done on the primary objective.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Partly
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

No

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Acute pain management, Transition from acute to chronic pain, Regional anesthesia, Adjuvants for pain managements, Nociception and EEG monitoring

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.

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Philippe Richebe, University of Montreal, Montreal, Canada
Samar Rafik Amin, Benha University, Benha, Egypt

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Reviewer Report

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29 Aug 2024 | for Version 1

Samar Rafik Amin, Benha University, Benha, Egypt

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Approved With Reservations

This protocol was proposed for conducting a comparative study between fentanyl and nalbuphine as adjuvant to local anesthetics during the subarachnoid block for lower abdominal gynecological surgeries based on randomized study design. the protocol is well written, however i have the following concerns:

1- Title includes the description as randomized controlled trial, but no control group in the methods. two active comparators will be compared without control group!
It is better to identify the type of operation as open not laparoscopic.

2- In the abstract :
Move the aim paragraph at the end of the background and the no need for outcomes paragraph separated from the methods. also, write the study design and duration in the methods

3- The introduction is where you build your hypothesis based on the previous literature. the study point of search has been utilized in many researches before ( fentanyl versus nalbuphine as local anesthetic adjuvants so, what are the conflicts or issues regarding previous reports , your study will try to resolve? clear this point in your hypothesis in the introduction.
Also, avoid repetition of your objectives many times .. enumerate them briefly in your study objectives then mention their details in the methods

4- Methods:
Add the anticipated study duration time.
Clarify the procedure as open not laparoscopic in the inclusion criteria
Mention the dermatomal level that will be established as onset level, and the bromage score that will be considered as onset of motor block.
Define the type of hemodynamic parameters (MAP -SBP- DBP- HR- CVP ... etc) that will be measured and the time points of measurements
define the duration time for Side effects follow up.

5- In sample size calculation: what is group C and group M ..
Please add the reference from which you obtained the mean and SD of the onset of sensory block. Additionally, sample size should be calculated based on the study 1ry outcome (duration of analgesia) not the 2ry outcome

Also, add a section to define the statistical analysis method.

6- Allocation concealment is a process of concealing the allocation sequence from the investigator responsible for recruiting patients, it is different from randomization.
Some standard methods of ensuring allocation concealment include sequentially numbered, opaque, sealed envelopes (SNOSE); sequentially numbered containers; pharmacy controlled randomization; and central randomization.

7- Define who will perform the block and the operation .. the same team or different ones ?

8- There is a discrepancy between the parameters that were mentioned in the measured outcomes and the collected data as you add the sedation score and the VAS score .. please unify your intended outcomes.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Yes

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Anaesthesia, pain therapy, perioperative medicine, 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.

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Reviewer Report

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24 Jun 2024 | for Version 1

Philippe Richebe, University of Montreal, Montreal, Canada

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Approved With Reservations

This is a study protocol proposed here.
Lower abdominal gynaecological surgeries could be more precise and better describe to avoid biases due to too many different types of approach which lead to different type and level of postoperative pain. Please avoid too much heterogeneity.
Nalbuphine and fentanyl will be added to the intrathecal injection of hyperbaric levobupivacaine. Intraoperative pain assessments and patients’ satisfaction could also be reported, not only intraoperative side effects or postoperative outcomes.
Primary outcome is duration of postoperative analgesia. This could be more precisely described. A better definition is warranted: time for 1^st need or requirement of analgesics? Time for the pain level to reach a certain threshold? … Please provide a clear and precise definition, also in the abstract.
Impact on hemodynamic parameters: the same protocol for blood pressure management as well as fluid loading must be respected and described precisely, so there is no bias due to heterogeneity in hypovolemia prior or during the anesthesia.
The procedure of blinding for the anesthesiologist and the research team who will follow-up on the patients must be clearly stated.
Power calculation: it seems that the power calculation was made using “onset of the sensory block”, but the primary objective of the study is not this outcome. The primary outcome is Time for requirement of analgesia. Power calculation must be done on the primary objective.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Partly
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

No

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Acute pain management, Transition from acute to chronic pain, Regional anesthesia, Adjuvants for pain managements, Nociception and EEG monitoring

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.

Respond to this report

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[1] 1. Ohnesorge H, Günther V, Grünewald M, et al.: Postoperative pain management in obstetrics and gynecology. J. Turk. Ger. Gynecol Assoc. 2020; 21: 287–297. PubMed Abstract | Publisher Full Text | Free Full Text

[2] 2. Khan AL, Singh RB, Tripathi RK, et al.: A comparative study between intrathecal dexmedetomidine and fentanyl as adjuvant to intrathecal bupivacaine in lower abdominal surgeries: A randomized trial. Anesth. Essays Res. 2015; 9: 139–148. PubMed Abstract | Publisher Full Text | Free Full Text

[3] 3. Prabhakaraiah UN, Narayanappa AB, Gurulingaswamy S, et al.: “Comparison of Nalbuphine Hydrochloride and Fentanyl as an Adjuvant to Bupivacaine for Spinal Anesthesia in Lower Abdominal Surgeries:” A Randomized, Double-blind Study. Anesth. Essays Res. 2017; 11: 859–863. PubMed Abstract | Publisher Full Text | Free Full Text

[4] 4. Edinoff AN, Kaplan LA, Khan S, et al.: Full Opioid Agonists and Tramadol: Pharmacological and Clinical Considerations. Anesthesiol. Pain Med. 2021; 11: e119156. PubMed Abstract | Publisher Full Text | Free Full Text

[5] 5. Gupta R, Verma R, Bogra J, et al.: A Comparative study of intrathecal dexmedetomidine and fentanyl as adjuvants to Bupivacaine. J. Anaesthesiol. Clin. Pharmacol. 2011; 27: 339–343. PubMed Abstract | Publisher Full Text | Free Full Text

[6] 6. Nazli B, Oguzalp H, Horasanli E, et al.: The Effects on Sensorial Block, Motor Block, and Haemodynamics of Levobupivacaine at Different Temperatures Applied in the Subarachnoid Space. Biomed. Res. Int. 2014; 2014: 132687–132687. PubMed Abstract | Publisher Full Text | Free Full Text

[7] 7. Mukherjee A, Pal A, Agrawal J, et al.: Intrathecal nalbuphine as an adjuvant to subarachnoid block: What is the most effective dose? Anesth. Essays Res. 2011; 5: 171–175. PubMed Abstract | Publisher Full Text | Free Full Text

[8] 8. Bajwa BS, Singh AP, Rekhi AK: Comparison of intrathecal clonidine and fentanyl in hyperbaric bupivacaine for spinal anesthesia and postoperative analgesia in patients undergoing lower abdominal surgeries. Saudi J. Anaesth. 2017; 11: 37–40. PubMed Abstract | Publisher Full Text | Free Full Text

[9] 9. Shah MS, Masoodi T, Hussain SY, et al.: Nalbuphine as an Intrathecal Adjuvant to 0.5% Hyperbaric Bupivacaine in Two Different Doses for Postoperative Analgesia After Abdominal Hysterectomy: A Prospective, Randomized, Double-Blind Control Study. Cureus. 14: e25044. PubMed Abstract | Publisher Full Text | Free Full Text

[10] 10. Sharma A, Chaudhary S, Kumar M, et al.: Comparison of nalbuphine versus fentanyl as intrathecal adjuvant to bupivacaine for orthopedic surgeries: A randomized controlled double-blind trial. J. Anaesthesiol. Clin. Pharmacol. 2021; 37: 529–536. PubMed Abstract | Publisher Full Text | Free Full Text

Randomised control trial comparing postoperative analgesia between nalbuphine and fentanyl as an adjuvant with intrathecal levobupivacaine for lower abdominal gynaecological surgeries

Abstract

Background

Methods

Outcomes

Aim

Keywords

Introduction

Primary objective

Secondary objectives

Methods

Inclusion criteria

Exclusion criteria

Interventions

Table 1. Doses for the two groups.

Outcomes

Recruitment

Sample size

Justification of sample size

Allocation

Blinding

Data collection process

Ethical considerations

Dissemination

Study status

Discussion

References

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