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CTRI Number  CTRI/2021/03/031729 [Registered on: 05/03/2021] Trial Registered Prospectively
Last Modified On: 24/02/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of two drugs in spinal anesthesia for pain relief in post operative period 
Scientific Title of Study   Comparison of Post Operative Analgesia between Intrathecal Nalbuphine VS Fentanyl in Spinal Anaesthesia - A Double blinded Randomised Controlled Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jananimadi 
Designation  Pg resident 
Affiliation  Pondicherry institute of medical sciences  
Address  Dept of anesthesia, Pondicherry institute of medical sciences, kalapet

Pondicherry
PONDICHERRY
605014
India 
Phone  9751110232  
Fax    
Email  jananimadi92.jm@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr hariharasudhan 
Designation  Assistant professor 
Affiliation  Pondicherry institute of medical sciences 
Address  Department of anesthesia, Pondicherry institute of medical sciences, kalapet

Pondicherry
PONDICHERRY
605014
India 
Phone  8861085422  
Fax    
Email  hsknight071@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr hariharasudhan 
Designation  Assistant professor 
Affiliation  Pondicherry institute of medical sciences  
Address  Department of anesthesia, Pondicherry institute of medical sciences, kalapet

Pondicherry
PONDICHERRY
605014
India 
Phone  8861085422  
Fax    
Email  hsknight071@gmail.com  
 
Source of Monetary or Material Support  
Pondicherry institute of medical sciences  
 
Primary Sponsor  
Name  Pims 
Address  Pondicherry institute of medical sciences, kalapet 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr jananimadi  Pondicherry institute of medical sciences  Anesthesia department
Pondicherry
PONDICHERRY 
9751110232

jananimadi92.jm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Fentanyl  0.5% bupivacaine 2.5ml and 25mcg fentanyl intrathecally 
Comparator Agent  Nalbuphine   0.5% bupivacaine 2.5ml and Nalbuphine 1mg intrathecally 
Intervention  Postoperative pain  Injection diclofenac 75mg iv stat 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1Patients belonging to ASA I & II
2Aged between 18 & 65 years
3 Patient undergoing elective infra umbilical surgeries 
 
ExclusionCriteria 
Details  1Patients with raised intracranial pressure or any intracranial pathology
2 Hypovolemia, Bradycardia
3 Patients on anticoagulants
4 Localised infection
5 Pregnant women
6 Allergy to local anaesthetics. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
to compare the duration of analgesia of nalbuphine and fentanyl in postoperative period in addition to bupivacaine in spinal anesthesia by using VAS score  24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1) to compare the onset and duration of sensory and motor blockade
2)to compare the hemodynamic parameters 
24hours 
 
Target Sample Size   Total Sample Size="166"
Sample Size from India="166" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   11/03/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="5"
Days="30" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Adding adjuvant drugs to intrathecal local anaesthetics improves quality and duration of sensory blockade and prolongs postoperative analgesia. Intrathecal opioids are synergistic with local anaesthetics, thereby intensifying the sensory block without increasing sympathetic block. (1) 

 

In 2016, wahi et al conducted with 30 patients in each group using bupivacaine with clonidine and studied the duration of sensory and motor block and concluded that addition of clonidine to bupivacaine intrathecally is a reliable method to prolong spinal anaesthesia but close monitoring for hypotension was to be noted.(4)

In 2012, safari et al did a study on 90 opium abuser patients were selected and randomly assigned into 3 groups. The patients received  bupivacaine-midazolam and  bupivacaine-fentanyl group; both were longer than the plain bupivacaine group. Therefore midazolam is more effective than fentanyl in such cases.(5)

Minagar et al conducted a study with one hundred patients between fifty patients were randomly allocated to receive dexmedetomidine and Bupivacaine and vital sign parameters were studied and concluded that intrathecal dexmedetomidine increases the duration of analgesia and reduces postoperative pain without changes in the hemodynamic parameters and adverse side effects. It can be considered as an appropriate adjuvant to intrathecal local anaesthetics for lower limb surgeries.(6)

Fernandez et al did a study with forty patients undergoing knee or hip replacement were studied. They received fentanyl with Bupivacaine and Bupivacaine and the results showed that 25 micrograms of spinal fentanyl do not modify spinal anaesthesia in the elderly, but induces pruritus and O2 desaturation. The decrease in postoperative pain intensity and the preservation of cognitive function would justify the use of spinal fentanyl in the elderly.(7)

A prospective, randomized, double-blind, and comparative study was conducted on 150 parturients in 2018 by bindra et al and were randomized into three groups with fifty patients in each group. They received bupivacaine with nalbuphine and bupivacaine with fentanyl and concluded intrathecal nalbuphine prolongs postoperative analgesia maximally and may be used as an alternative to intrathecal fentanyl in cesarean section(8)

There are very few large studies that have compared intrathecal nalbuphine with intrathecal fentanyl added to hyperbaric bupivacaine infra umbilical surgeries. Therefore, we designed a randomized double-blind study to compare the effects of intrathecal nalbuphine and fentanyl as adjuvants to bupivacaine patients undergoing infra umbilical surgeries. The aim of this study was to compare fentanyl with nalbuphine as intrathecal adjuvant to 0.5% hyperbaric bupivacaine in terms of sensory and motor blockade characteristics and duration of postoperative analgesia and hemodynamic changes.

 
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