To assess the efficacy of injection nalbuphine as an adjuvant to intrathecal bupivacaine in endoscopic urological surgeries for prolongation of postoperative analgesia

Saiesh Raut Dessai; Dr. Sanjot Ninave; Amol Bele; Nitin Alaspukar

doi:10.12688/f1000research.133274.1

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Study Protocol

To assess the efficacy of injection nalbuphine as an adjuvant to intrathecal bupivacaine in endoscopic urological surgeries for prolongation of postoperative analgesia

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

Saiesh Raut Dessai ¹, Dr. Sanjot Ninave¹, Amol Bele¹, Nitin Alaspukar¹

PUBLISHED 04 May 2023

Author details Author details

¹ Department of Anaesthesia, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education & Research, Wardha, Maharashtra, 442001, India

Saiesh Raut Dessai
Roles: Conceptualization, Data Curation, Methodology, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Dr. Sanjot Ninave
Roles: Conceptualization, Data Curation, Supervision, Visualization, Writing – Review & Editing

Amol Bele
Roles: Supervision

Nitin Alaspukar
Roles: Supervision

OPEN PEER REVIEW

REVIEWER STATUS

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

Abstract

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.

Keywords

Nalbuphine, Endoscopic urological Surgeries, Bupivacaine, Postoperative pain

Corresponding author: Saiesh Raut Dessai

Competing interests: No competing interests were disclosed.

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

Copyright: © 2023 Raut Dessai S et al. 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: Raut Dessai S, Ninave DS, Bele A and Alaspukar N. To assess the efficacy of injection nalbuphine as an adjuvant to intrathecal bupivacaine in endoscopic urological surgeries for prolongation of postoperative analgesia [version 1; peer review: 1 approved, 1 approved with reservations]. F1000Research 2023, 12:466 (https://doi.org/10.12688/f1000research.133274.1) First published: 04 May 2023, 12:466 (https://doi.org/10.12688/f1000research.133274.1) Latest published: 04 May 2023, 12:466 (https://doi.org/10.12688/f1000research.133274.1)

Introduction

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.¹ The spinal adjuvants are the most frequently used to extend postsurgical analgesia.²

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.³ Almost all general anesthesia and regional anesthesia treatments employ it. Nalbuphine causes analgesia by its action on kappa receptors that are present in the central nervous system. Additionally, Adjuvant enhances perioperative analgesia quality while reducing adverse actions.⁴ It is a hybrid synthetic agonistic antagonist that leads to both increases and attenuation of the actions of opioids.⁵

Nalbuphine can counteract the negative effects of spinal opiates because, when administered systemically, it has a less rate of causing depression in respiratory system.⁶ When compared to intrathecal morphine, intravenous nalbuphine has fewer adverse effects, which include itching, vomiting,⁷ and does not appear to have any significant respiratory or hemodynamic side effects.⁸

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.

Protocol

Aim

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.

Objectives

Primary objective

To compare the duration of postoperative analgesia between Intrathecal Bupivacaine alone and with Injection Nalbuphine as an adjuvant to Injection Bupivacaine.

Secondary objectives

1) To compare the effect on hemodynamic parameters.
2) The commence and duration of sensory and motor block.
3) Adverse consequences (sedation degree, postoperative nausea, vomiting, shivering, urinary retention, and any other)

Methods

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.

Study design

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.

Inclusion criteria

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

Exclusion criteria

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

Sampling size

The study will involve 60 participants who meet all inclusion requirements.

Two study groups will be randomly selected among the study's participants (Table 1):

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)

Table 1. Control group vs study group.

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

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.

Justification of sample size

The calculation of sample size is based on:

Sample size formula for difference between two means

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

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

σ₁ = SD of onset of sensory block in group C = 1.05

σ₂ = SD of onset of sensory block in group M = 0.44

Δ = 3.04 – 1.95 = 0.61 and k = 1

\begin{array}{c} n = \frac{{(1.96 + 0.84)}^{2} [{1.05}^{2} + {0.44}^{2} / 1]}{{0.61}^{2}} = 27.30 \end{array}

n = 30

➢ Reference = VK Chandra sample size determination in health studies, NTI Bulletin, 2006, 42/3 and 4, 55-62.

Methods

Pre-operative assessment

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 (Table 1).

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)

Intraoperative

i. An ECG, pressure monitor, and spo2 probe will be attached intraoperatively.
ii. 18g iv cannula will be used to secure an IV line, and fluid @ 10- to 15 ml/kg of Ringer Lactate will be given.
iii. Baseline vitals: Lead II's electrocardiogram will be continuously shown, Oxygen saturation, blood pressure, and heart rate will also be recorded for the patient.
iv. Premedication will be administered to all patients. 10 minutes before the anesthesia procedure, provide ondansetron 75–100 mcg/kg intravenously.
v. 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.

1. The motor and sensory paralysis onset.
2. Highest level of sensory blocking that is reached and the length of time it takes to reach that level will be reported.
3. The sensory blockade's two-segment regression time
4. Sedation level
5. VAS postoperative pain evaluation
6. When to use rescue analgesia
7. 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.

Block evaluation

Sensory block

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.

DURATION OF SENSORY BLOCKADE

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.

MOTOR BLOCKADE

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.

Discussion

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.⁸^,⁹ Administering nalbuphine to patients undergoing surgery under spinal anesthesia (SAB) can prolong their pain relief without causing an increase in motor block duration. Our study also found that the inclusion of nalbuphine substantially prolonged the duration of analgesia in patients undergoing surgery but did not have any significant impact on the duration of motor block.

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.⁷ Another study conducted on patients undergoing hip surgeries also reported similar findings.¹⁰ Based on our study's results, it appears that nalbuphine can be a valuable adjuvant for patients undergoing endoscopic urological surgeries using spinal anesthesia. Our findings demonstrated that nalbuphine effectively extended analgesia.

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.¹¹ In a study for lower limb anesthesia, it was concluded the addition of 800 mg of nalbuphine and 25 mg of butorphanol as an adjuvant to intrathecal bupivacaine produced better results than the active placebo group. But when it came to extending postoperative analgesia, intrathecal nalbuphine outperformed intrathecal butorphanol.¹² 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.¹³

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.¹⁴

Dissemination

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.

Study status

Control group data collection ongoing.

Discussion

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.⁸^,⁹ Administering nalbuphine to patients undergoing surgery under spinal anesthesia (SAB) can prolong their pain relief without causing an increase in motor block duration. Our study also found that the inclusion of nalbuphine substantially prolonged the duration of analgesia in patients undergoing surgery but did not have any significant impact on the duration of motor block.

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.⁷ Another study conducted on patients undergoing hip surgeries also reported similar findings.¹⁰ Based on our study's results, it appears that nalbuphine can be a valuable adjuvant for patients undergoing endoscopic urological surgeries using spinal anesthesia. Our findings demonstrated that nalbuphine effectively extended analgesia.

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.¹¹ In a study for lower limb anesthesia, it was concluded the addition of 800 mg of nalbuphine and 25 mg of butorphanol as an adjuvant to intrathecal bupivacaine produced better results than the active placebo group. But when it came to extending postoperative analgesia, intrathecal nalbuphine outperformed intrathecal butorphanol.¹²

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.¹³ 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.¹⁴

Ethical considerations

INSTITUTIONAL ETHICS committee approved research to be carried out at JAWAHARLAL NEHRU MEDICAL COLLEGE, SAWANGI. Reference number DMIMS (DU)/II/C/2022/93.

Data availability

No data are associated with this article.

Acknowledgements

The author would like to acknowledge the support from staff of Department of Anaesthesia, JNMC, AVBRH, Sawangi, Wardha, India.

References

1. Bogra J, Arora N, Srivastava P: Synergistic effect of intrathecal fentanyl and bupivacaine in spinal anesthesia for cesarean section. BMC Anesthesiol. 2005 Dec; 5(1): 5. PubMed Abstract | Publisher Full Text | Free Full Text
2. Swain A, Nag DS, Sahu S, et al.: Adjuvants to local anesthetics: Current understanding and future trends. World J. Clin. Cases. 2017; 5(8): 307–323. PubMed Abstract | Publisher Full Text | Free Full Text
3. Gupta K, Rastogi B, Gupta P, et al.: Intrathecal nalbuphine versus intrathecal fentanyl as adjuvant to 0.5% hyperbaric bupivacaine for orthopedic surgery of lower limbs under subarachnoid block: A comparative evaluation. Indian J. Pain. 2016; 30(2): 90. Publisher Full Text
4. Gunion MW, Marchionne AM, Anderson CTM: Use of the mixed agonist–antagonist nalbuphine in opioid based analgesia. Acute Pain. 2004 Jun; 6(1): 29–39. Publisher Full Text
5. Schmauss C, Doherty C, Yaksh TL: The analgetic effects of an intrathecally administered partial opiate agonist, nalbuphine hydrochloride. Eur. J. Pharmacol. 1982 Dec; 86(1): 1–7. PubMed Abstract | Publisher Full Text
6. Penning JP, Samson B, Baxter AD: Reversal of epidural morphine-induced respiratory depression and pruritus with nalbuphine. Can. J. Anaesth. 1988 Nov; 35(6): 599–604. PubMed Abstract | Publisher Full Text
7. Culebras X, Gaggero G, Zatloukal J, et al.: Advantages of Intrathecal Nalbuphine, Compared with Intrathecal Morphine, After Cesarean Delivery: An Evaluation of Postoperative Analgesia and Adverse Effects. Anesth. Analg. 2000 Sep; 91: 601–605. PubMed Abstract
8. Tiwari AK, Tomar GS, Agrawal J: Intrathecal Bupivacaine in Comparison With a Combination of Nalbuphine and Bupivacaine for Subarachnoid Block: A Randomized Prospective Double-Blind Clinical Study. Am. J. Ther. 2013 Nov; 20(6): 592–595. PubMed Abstract | Publisher Full Text
9. 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(2): 171–175. PubMed Abstract | Publisher Full Text
10. Fournier R, Van Gessel E, Macksay M, et al.: Onset and offset of intrathecal morphine versus nalbuphine for postoperative pain relief after total hip replacement: Intrathecal morphine versus nalbuphine. Acta Anaesthesiol. Scand. 2000 Sep; 44(8): 940–945. PubMed Abstract | Publisher Full Text
11. 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. 2022 May 16 [cited 2023 Mar 14]. Reference Source
12. Kumari A, Kullar K, Gupta R: Duration of postoperative analgesia with Nalbuphine vs Butorphanol as an adjunct to spinal anesthesia for lower limb orthopedic surgeries: A randomized double-blind active control trial. J. Anaesthesiol. Clin. Pharmacol. 2021; 37(4): 592–597. PubMed Abstract | Publisher Full Text
13. Kaushal S, Kamlakar M, Baburao J: Intrathecal nalbuphine vs. buprenorphine as an adjuvant in lower limb orthopedic surgeries: a prospective randomized controlled study. Med. Gas Res. 2021; 11(4): 126–130. PubMed Abstract | Publisher Full Text
14. Prajapati D, Patel M, Patel P, et al.: Effect of caudal bupivacaine alone and with adjuvant fentanyl and nalbuphine to minimize the catheter-related bladder discomfort after tubeless percutaneous nephrolithotomy: A prospective randomized study. J. Anaesthesiol. Clin. Pharmacol. 2020; 36(4): 524–530. PubMed Abstract | Publisher Full Text | Free Full Text

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Version 1

VERSION 1 PUBLISHED 04 May 2023

Author details Author details

¹ Department of Anaesthesia, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education & Research, Wardha, Maharashtra, 442001, India

Saiesh Raut Dessai
Roles: Conceptualization, Data Curation, Methodology, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Dr. Sanjot Ninave
Roles: Conceptualization, Data Curation, Supervision, Visualization, Writing – Review & Editing

Amol Bele
Roles: Supervision

Nitin Alaspukar
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: 04 May 2023, 12:466

https://doi.org/10.12688/f1000research.133274.1

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© 2023 Raut Dessai S et al. 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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Raut Dessai S, Ninave DS, Bele A and Alaspukar N. To assess the efficacy of injection nalbuphine as an adjuvant to intrathecal bupivacaine in endoscopic urological surgeries for prolongation of postoperative analgesia [version 1; peer review: 1 approved, 1 approved with reservations]. F1000Research 2023, 12:466 (https://doi.org/10.12688/f1000research.133274.1)

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Reviewer Report 25 Jul 2024

Manisha S. Kapdi, Anaesthesia, Narendra Modi Medical Collage, Ahmedabad, India

Approved

https://doi.org/10.5256/f1000research.146253.r289246

Design, Objectives of the study are perfect.
In methodology intervention, grouping ,Randomization are properly defined.
Data management& statistical analysis satisfactory.
Observations, results & Discussion are in scientific manner
Present study evaluates efficacy of opioid Nalbuphine to ... Continue reading

Design, Objectives of the study are perfect.
In methodology intervention, grouping ,Randomization are properly defined.
Data management& statistical analysis satisfactory.
Observations, results & Discussion are in scientific manner
Present study evaluates efficacy of opioid Nalbuphine to intrathecal Bupivacaine for
Endoscopic Urosurgery patients in terms of postoperative analgesia & hemodynamic stability. References are enlisted properly.
At last conclusion of research question in very effective manner

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?

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

Yes

Competing Interests: No competing interests were disclosed.

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.

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Reviewer Report 21 Jun 2024

Samar Rafik Amin, Benha University, Benha, Egypt

Approved with Reservations

https://doi.org/10.5256/f1000research.146253.r289243

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, ... Continue reading

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

Partly
Is the study design appropriate for the research question?

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

Competing Interests: No competing interests were disclosed.

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.

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Samar Rafik Amin, Benha University, Benha, Egypt
Manisha S. Kapdi, Narendra Modi Medical Collage, Ahmedabad, India

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25 Jul 2024 | for Version 1

Manisha S. Kapdi, Anaesthesia, Narendra Modi Medical Collage, Ahmedabad, India

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Approved

Design, Objectives of the study are perfect.
In methodology intervention, grouping ,Randomization are properly defined.
Data management& statistical analysis satisfactory.
Observations, results & Discussion are in scientific manner
Present study evaluates efficacy of opioid Nalbuphine to intrathecal Bupivacaine for
Endoscopic Urosurgery patients in terms of postoperative analgesia & hemodynamic stability. References are enlisted properly.
At last conclusion of research question in very effective manner

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?

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

Yes

Competing Interests

No competing interests were disclosed.

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.

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Reviewer Report

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21 Jun 2024 | for Version 1

Samar Rafik Amin, Benha University, Benha, Egypt

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Approved With Reservations

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

Partly
Is the study design appropriate for the research question?

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

Competing Interests

No competing interests were disclosed.

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.

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[1] 1. Bogra J, Arora N, Srivastava P: Synergistic effect of intrathecal fentanyl and bupivacaine in spinal anesthesia for cesarean section. BMC Anesthesiol. 2005 Dec; 5(1): 5. PubMed Abstract | Publisher Full Text | Free Full Text

[2] 2. Swain A, Nag DS, Sahu S, et al.: Adjuvants to local anesthetics: Current understanding and future trends. World J. Clin. Cases. 2017; 5(8): 307–323. PubMed Abstract | Publisher Full Text | Free Full Text

[3] 3. Gupta K, Rastogi B, Gupta P, et al.: Intrathecal nalbuphine versus intrathecal fentanyl as adjuvant to 0.5% hyperbaric bupivacaine for orthopedic surgery of lower limbs under subarachnoid block: A comparative evaluation. Indian J. Pain. 2016; 30(2): 90. Publisher Full Text

[4] 4. Gunion MW, Marchionne AM, Anderson CTM: Use of the mixed agonist–antagonist nalbuphine in opioid based analgesia. Acute Pain. 2004 Jun; 6(1): 29–39. Publisher Full Text

[5] 5. Schmauss C, Doherty C, Yaksh TL: The analgetic effects of an intrathecally administered partial opiate agonist, nalbuphine hydrochloride. Eur. J. Pharmacol. 1982 Dec; 86(1): 1–7. PubMed Abstract | Publisher Full Text

[6] 6. Penning JP, Samson B, Baxter AD: Reversal of epidural morphine-induced respiratory depression and pruritus with nalbuphine. Can. J. Anaesth. 1988 Nov; 35(6): 599–604. PubMed Abstract | Publisher Full Text

[7] 7. Culebras X, Gaggero G, Zatloukal J, et al.: Advantages of Intrathecal Nalbuphine, Compared with Intrathecal Morphine, After Cesarean Delivery: An Evaluation of Postoperative Analgesia and Adverse Effects. Anesth. Analg. 2000 Sep; 91: 601–605. PubMed Abstract

[8] 8. Tiwari AK, Tomar GS, Agrawal J: Intrathecal Bupivacaine in Comparison With a Combination of Nalbuphine and Bupivacaine for Subarachnoid Block: A Randomized Prospective Double-Blind Clinical Study. Am. J. Ther. 2013 Nov; 20(6): 592–595. PubMed Abstract | Publisher Full Text

[9] 9. 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(2): 171–175. PubMed Abstract | Publisher Full Text

[10] 10. Fournier R, Van Gessel E, Macksay M, et al.: Onset and offset of intrathecal morphine versus nalbuphine for postoperative pain relief after total hip replacement: Intrathecal morphine versus nalbuphine. Acta Anaesthesiol. Scand. 2000 Sep; 44(8): 940–945. PubMed Abstract | Publisher Full Text

[11] 11. 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. 2022 May 16 [cited 2023 Mar 14]. Reference Source

[12] 12. Kumari A, Kullar K, Gupta R: Duration of postoperative analgesia with Nalbuphine vs Butorphanol as an adjunct to spinal anesthesia for lower limb orthopedic surgeries: A randomized double-blind active control trial. J. Anaesthesiol. Clin. Pharmacol. 2021; 37(4): 592–597. PubMed Abstract | Publisher Full Text

[13] 13. Kaushal S, Kamlakar M, Baburao J: Intrathecal nalbuphine vs. buprenorphine as an adjuvant in lower limb orthopedic surgeries: a prospective randomized controlled study. Med. Gas Res. 2021; 11(4): 126–130. PubMed Abstract | Publisher Full Text

[14] 14. Prajapati D, Patel M, Patel P, et al.: Effect of caudal bupivacaine alone and with adjuvant fentanyl and nalbuphine to minimize the catheter-related bladder discomfort after tubeless percutaneous nephrolithotomy: A prospective randomized study. J. Anaesthesiol. Clin. Pharmacol. 2020; 36(4): 524–530. PubMed Abstract | Publisher Full Text | Free Full Text

To assess the efficacy of injection nalbuphine as an adjuvant to intrathecal bupivacaine in endoscopic urological surgeries for prolongation of postoperative analgesia

Abstract

Keywords

Introduction

Protocol

Aim

Objectives

Methods

Study design

Inclusion criteria

Exclusion criteria

Sampling size

Table 1. Control group vs study group.

Statistical analysis

Justification of sample size

Methods

Intraoperative

Block evaluation

Discussion

Discussion

Ethical considerations

Data availability

Acknowledgements

References

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