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CTRI Number  CTRI/2025/10/096062 [Registered on: 14/10/2025] Trial Registered Prospectively
Last Modified On: 20/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   "Comparing Two Pain Medications to Improve Pain Relief in Leg Surgery"  
Scientific Title of Study   "A comparative study of intrathecal Nalbuphine and Buprenorphine as an adjuvant to 0.5% hyperbaric Bupivacaine in lower limb orthopedic surgeries"  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanjana M B 
Designation  Post Graduate 
Affiliation  Bangalore Medical College and Research Institute 
Address  Department of Anaesthesia, Bangalore Medical College and Research Institute, Fort, Krishna Rajendra Rd, Kalasipalya, Bengaluru, Karnataka 560002

Bangalore
KARNATAKA
560002
India 
Phone  9741092570  
Fax    
Email  sanjumoodi1999@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Soumya Rohit  
Designation  Assistant Professor 
Affiliation  Bangalore Medical College and Research Institute 
Address  Department of Anaesthesia, Bangalore Medical College and Research Institute, Fort, Krishna Rajendra Rd, Kalasipalya, Bengaluru, Karnataka 560002

Bangalore
KARNATAKA
560002
India 
Phone  9611106641  
Fax    
Email  dr.soumyarohit@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Soumya Rohit  
Designation  Assistant Professor 
Affiliation  Bangalore Medical College and Research Institute 
Address  Department of Anaesthesia, Bangalore Medical College and Research Institute, Fort, Krishna Rajendra Rd, Kalasipalya, Bengaluru, Karnataka 560002

Bangalore
KARNATAKA
560002
India 
Phone  9611106641  
Fax    
Email  dr.soumyarohit@gmail.com  
 
Source of Monetary or Material Support  
Victoria Hospital, BMCRI, Mysore Rd, near City Market, New Tharagupet, Bengaluru, Karnataka 560002 
 
Primary Sponsor  
Name  Dr Sanjana M B 
Address  Department of Anaesthesia, Bangalore Medical College and Research Institute, Fort, Krishna Rajendra Rd, Kalasipalya, Bengaluru, Karnataka 560002 Department of Anaesthesia, Bangalore Medical College and Research Institute, Fort, Krishna Rajendra Rd, Kalasipalya, Bengaluru, Karnataka 560002 
Type of Sponsor  Other [Self] 
 
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 Sanjana M B  Victoria Hospital  Department of Anaesthesia, Bangalore Medical College and Research Institute, Fort, Krishna Rajendra Rd, Kalasipalya, Bengaluru, Karnataka 560002
Bangalore
KARNATAKA 		 9741092570

sanjumoodi1999@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Bangalore Medical College and Research Institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S729||Unspecified fracture of femur, (2) ICD-10 Condition: S829||Unspecified fracture of lower leg, (3) ICD-10 Condition: S999||Unspecified injury of ankle and foot, (4) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Buprenorphine  Intrathecal Buprenorphine 60mcg will be used as an adjuvant to hyperbaric bupivacaine. 
Intervention  Nalbuphine  Intrathecal Nalbuphine 0.4mg will be used as an adjuvant to hyperbaric bupivacaine 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients willing to give informed written consent
2. American Society of Anaesthesiologists physical status grade I –II aged between 18- 60 years
3. Patients weighing 50-80kgs, Patients of height 150-170cms with BMI of 22.2 to 27.7
4. Scheduled to undergo lower limb orthopaedic surgeries 
 
ExclusionCriteria 
Details  1. Allergy to local anaesthetics
2. Infection at the site of injection
3. Coagulopathy
4. Chronic pain syndromes
5. Prolonged opioid medication
6. Chronic liver disease, chronic renal disease, and cognitive impairment
7. Combined spinal epidural anaesthesia
8. Surgeries exceeding 6 hours
9. Surgeries that are converted to general anesthesia
10. Morbid obesity (BMI more than 40)
11. Pregnancy, parturients and nursing mothers 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the duration of analgesia  Post operative pain will be assessed every 60 mins for 4 hours from onset of analgesia 
 
Secondary Outcome  
Outcome  TimePoints 
1.To assess the onset of sensory & motor blockade
2.To assess the duration of motor blockade
3.To compare the hemodynamics
4.To assess the side effects encountered if any 		 Hemodynamic parameters will be assessed at 0, 1, 3, 5, 10, 15, 30, 60, 90, 120, 180 mins
 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   28/10/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  28/10/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This study is a randomized double blind parallel group trial comparing the duration of analgesia between intrathecal Nalbuphine and Buprenorphine as an adjuvant to 0.5% hyperbaric Bupivacaine in lower limb orthopedic surgeries in 120 patients for 18 months. The primary outcome will be to compare the duration of analgesia. The secondary outcomes will be to assess onset of sensory and motor blockade, to assess duration of motor blockade, to compare hemodynamics and to assess the side effects if any. 
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