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CTRI Number  CTRI/2024/05/066998 [Registered on: 08/05/2024] Trial Registered Prospectively
Last Modified On: 05/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To study the effect of drug in patients undergoing upper limb surgeries via nerve block 
Scientific Title of Study   Effect of buprenorphine as an adjunct to local aneasthetic mixtures in ultrasound guided supraclavicular brachial plexus block in patients undergoing upper limb surgeries - a Randomized Controlled study. 
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. Thenmozhi 
Designation  Junior resident 
Affiliation  Pondicherry Institute of Medical Sciences 
Address  Department of Anaesthesiology, Pondicherry Institute of Medical Sciences, kalapet Pondicherry PONDICHERRY 605014 India

Pondicherry
PONDICHERRY
605014
India 
Phone  9345062218  
Fax    
Email  thenmozhibaskaran748@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Arish BT 
Designation  Associate professor 
Affiliation  Pondicherry Institute of Medical Sciences 
Address  Department of Anaesthesiology, Pondicherry Institute of Medical Sciences campus,kalapet Pondicherry PONDICHERRY 605014 India

Pondicherry
PONDICHERRY
605014
India 
Phone  9791853400  
Fax    
Email  ajstyle.bt@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Thenmozhi 
Designation  Junior resident 
Affiliation  Pondicherry Institute of Medical Sciences 
Address  Department of Anaesthesiology, Pondicherry Institute of Medical Science, kalapet, Pondicherry PONDICHERRY 605014 India

Pondicherry
PONDICHERRY
605014
India 
Phone  9345062218  
Fax    
Email  thenmozhibaskaran748@gmail.com  
 
Source of Monetary or Material Support  
Pondycherry institute of medical sciences, Kalapet,Pondycherry 605014 PONDICHERRY India 
 
Primary Sponsor  
Name  Pondicherry Institute of Medical Sciences 
Address  Department of Anaesthesiology, Pondicherry Institute of Medical Sciences campus,kalapet Pondicherry PONDICHERRY 605014 India  
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 Thenmozhi  Pondicherry Institute of Medical Sciences Hospital  Department of Anaesthesiology, Pondicherry Institute of Medical Sciences campus,kalapet Pondicherry PONDICHERRY 605014 India
Pondicherry
PONDICHERRY 		 9345062218

thenmozhibaskaran748@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PIMS INSTITUTE ETHICS 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  buprenorphine  patients will be given 300mcg of buprenorphine along with 9ml of 0.5% bupivacaine + 9ml of 2% lignocaine with adrenaline in ultrasound guided supraclavicular brachial plexus block. the duration of sensory blockade will be seen introperatively from the onset of sensory blockade and postoperatively every hour for first 16 hours till the complete resolution . 
Comparator Agent  normal saline   patient will be given 9ml of 0.5% bupivacaine + 9ml of 2% lignocaine with adrenaline along with 2ml of normal saline in ultrasound guided supraclavicular brachial plexus block. the duration of sensory blockade will be assessed intraoperatively from the time of onset of sensory blockade till complete resolution every hour for the first 16 hours in the postoperative period. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.patients undergoing elective elbow,forearm ,hand surgeries.
2.aged between 18 and 60 years of either gender
3.patients belonging to ASA physical status 1, 2  
 
ExclusionCriteria 
Details  1.BMI more than or equal to 35kg per meter squared.
2.allergy to local anesthetics/opioids
3.patients on opioids for chronic use
4.puncture site infection
5.preexisting nerve injury
6.coagulopathy. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
duration of sensory blockade in ultrasound guided supraclavicular brachial plexus block in patients undergoing upper limb surgeries.   duration of sensory blockade is assessed from the time of onset of sensory blockade to complete resolution of blockade. it will be assessed every hour in the first 16 hours in the postoperative period . 
 
Secondary Outcome  
Outcome  TimePoints 
1.time taken for onset of sensory and motor blockade
2.duration of motor blockade
3.level of sedation using ramsay sedation scale
4. to assess hemodynamic effects  		 the above mentioned parameters are assessed intraoperatively and postoperatively every hour for the first 16 hours  
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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 4 
Date of First Enrollment (India)   20/05/2024 
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="11"
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 is a prospective randomized controlled trial to be conducted on patients aged 18 to 60 years belonging to ASA1 and ASA2 posted for elective upper limb surgeries under regional aneasthesia.  After getting consent , patients were allocated into two groups . group A will be be given 9ml of 0.5% of bupivacaine + 9ml of 2% lignocaine with adrenaline along with 300mcg of buprenorphine diluted to 1 ml of normal saline . group B will be given 9ml of 0.5 % bupivacaine + 9ml of 2% lignocaine with adrenaline along with 2ml of normal saline .  The duration of sensory blockade is compared between two groups.  
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