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CTRI Number  CTRI/2025/04/084623 [Registered on: 11/04/2025] Trial Registered Prospectively
Last Modified On: 10/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing Epidural Buprenorphine vs Epidural Tramadol for management of pain after operation in patients undergoing replacement surgeries 
Scientific Title of Study   A Prospective study to compare epidural buprenorphine versus epidural tramadol for post operative analgesia in lower limb orthopedic replacement 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  Akashi Shah 
Designation  Resident doctor 
Affiliation  Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Anaesthesia Department, General Ot Complex, 2nd Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre,Sumandeep, Waghodiya, Piparia ,Vadodara,GUJARAT,391760

Vadodara
GUJARAT
391730
India 
Phone  8980009010  
Fax    
Email  akashishah7@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sara Mary Thomas 
Designation  HOD 
Affiliation  Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Anaesthesia Department, General Ot Complex, 2nd Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Piparia ,Vadodara,GUJARAT,391760

Vadodara
GUJARAT
391760
India 
Phone  9646500158  
Fax    
Email  sara.cinosh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sara Mary Thomas 
Designation  Professor and HOD 
Affiliation  Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Anaesthesia Department, General Ot Complex, 2nd Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre,Sumandeep,Waghodiya, Piparia ,Vadodara,GUJARAT,391760

Vadodara
GUJARAT
391760
India 
Phone  9646500158  
Fax    
Email  sara.cinosh@gmail.com  
 
Source of Monetary or Material Support  
Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Wagodhia , Pipariya, Vadodara, Gujarat , India Pincode- 391760 
 
Primary Sponsor  
Name  Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre,  
Address  Wagodhia , Pipariya, Vadodara, Gujarat , India Pincode- 391760 
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 Sara Mary Thomas  Dhiraj Hospital  Anaesthesia Department, General Ot Complex, 2nd Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Piparia ,Vadodara,GUJARAT,391760
Vadodara
GUJARAT 		 09646500158

sara.cinosh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
sumandeep vidyapeeth institutional ethical committee  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 
Intervention  Group B(Buprenorphine group)  Group B(Buprenorphine group) will receive Inj.buprenorphine 100mcg diluted with Normal saline to make a total volume of 10ml given via epidural route after patient shifted to recovery room. The dose is given only once after the onset of pain following surgery irrespective of time duration after the surgery. 
Comparator Agent  Group T(Tramadol group)   Group T(Tramadol group) will receive Inj. Tramadol 50 mg diluted with normal saline to make a total volume of 10ml given via epidural route after patient shifted to recovery room. The dose is given only once after the onset of pain following surgery irrespective of time duration after the surgery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Patient willing to sign the written informed consent.
2)Patients belonging to American Society of Anaesthesiologists (ASA)Grade I or
II
3)Male or female patients between age range of 18 and 60 years.
4)Patients undergoing elective lower limb orthopedic replacement surgeries under
spinal anaesthesia. 
 
ExclusionCriteria 
Details  1)Patients unwilling to participate in the study.
2) Patients belonging to ASA Grade III or more.  Pregnant or lactating woman.
3)History of known allergy to study drug.
4)Patients having any vertebral anomalies. 5)Patients who needs supplementation of general anaesthesia.
6)Any contraindication to Epidural Anaesthesia (local site infection, coagulation disorder, raised intacranial pressure, hemodynamic instability, neurological disorders). 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
This observational study will help us to know between epidural buprenorphine and epidural tramadol which drug provides better postoperative analgesia
with minimal side effects in patients undergoing lower limb replacement surgeries. 		 postoperatively,the study drug will be administered via epidural route when VAS more than equal to 4.
* The VAS before administration of drug is considered as "Base Line".
* VAS is noted immediately after administration of drug
* VAS is noted at 1st, 2nd, 3rd, 4th and so on till 12th hour after the administration of the drug via epidural route. 
 
Secondary Outcome  
Outcome  TimePoints 
to compare the hemodynamics of the two groups.  vitals will be taken at baseline,15mminutes, 30 minutes, 60 minutes, 120 minutes, 240 minutes.
Baseline vitals will be marked before epidural injection. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   21/04/2025 
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="0"
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   A Prospective study to compare epidural buprenorphine versus epidural tramadol for post operative analgesia in lower limb orthopedic replacement surgeries

AIM

The aim of study is to compare post operative analgesic efficacy of epidural tramadol versus epidural buprenorphine in lower limb orthopedic replacement surgery.

OBJECTIVES

· To compare the onset, total duration and quality of analgesia between the groups.

· To compare the haemodynamic changes between the study groups.

 

INCLUSION CRITERIA:

Patient willing to sign the written informed consent.

Patients belonging to American Society of Anaesthesiologists (ASA) Grade I or II

Male or female patients between age range of 18- 60 years.

lPatients undergoing elective lower limb orthopedic replacement surgeries under spinal anaesthesia.

 

 EXCLUSION CRITERIA:

Patients unwilling to participate in the study.

Patients belonging to ASA Grade III or more.

Pregnant or lactating woman.

History of known allergy to study drug.

Patients having any vertebral anomalies.

Patients who needs supplementation of general anaesthesia.

Any contraindication to Epidural Anaesthesia (local site infection, coagulation disorder, raised intacranial pressure, hemodynamic instability, neurological disorders).


Methods:

The Randomised Prospective Observational Study will be conducted in Department of Anaesthesiology in Dhiraj hospital. After approval from instituitional ethics committee the study will be conducted to compare epidural buprenorphine and epidural tramadol for post operative analgesia in  60 patients undergoing lower limb orthopedic replacement surgeries, aged 18 to 60 years.

Patients will be randomly allocated using computer generated random numbers into two groups: Group B and Group T of 60 patients each.

60 patients will be randomly divided by computer generated random numbers into 2 groups of 30 patients each :

 Group B will receive epidurally 100 mcg of buprenorphine diluted with normal saline to make a total volume of 10ml.

Group T will receive epidurally 50mg of tramadol diluted with normal saline to make a total volume of 10ml.

 

The procedure will be performed by the anaesthesiologist not related to study. All the patients will be explained clearly about the purpose and nature of the study in the language they can understand. They will be included in the study only after obtaining a written informed consent.

Study site: Dhiraj hospital, S.B.K.S. Medical institute and research center, Sumandeep vidyapeeth deemed to be university,piparia,vadodara,Gujarat.

Study design: Randomized Prospective Observational Study


likely outcome of the study:
This prospective and observational study will help us to compare between epidural buprenorphine and epidural tramadol which drug provides superior postoperative analgesia with fewer side effects and is a more effective option for patients undergoing lower limb orthopaedic replacement surgeries.
 
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