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CTRI Number  CTRI/2020/07/026494 [Registered on: 10/07/2020] Trial Registered Prospectively
Last Modified On: 16/07/2020
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   A COMPARISON BETWEEN TWO GROUPS WITH 0.5% BUPIVACAINE(LOCAL ANESTHETIC AGENT) AND 0.5% BUPIVACAINE WITH PENTAZOCINE,AN OPIOID ANALGESIC, AS AN ADDITIVE FOR POST OPERATIVE PAIN RELIEF IN UPPER LIMB SURGERY BY SUPRACLAVICULAR BRACHIAL PLEXUS NERVE BLOCK WHICH BLOCKS NERVE SUPPLY OF UPPER LIMB 
Scientific Title of Study   A PROSPECTIVE,RANDOMISED, DOUBLE BLINDED COMPARATIVE STUDY BETWEEN 0.5% BUPIVACAINE AND 0.5% BUPIVACAINE WITH PENTAZOCINE AS AN ADJUVANT IN SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK FOR POST OPERATIVE ANALGESIA IN UPPER LIMB SURGERY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DEBMALYA MUKHERJEE 
Designation  1st YEAR POST GRADUATE TRAINEE DEPARTMENT OF ANAESTHESIOLOGY  
Affiliation  MIDNAPORE MEDICAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF ANAESTHESIOLOGY MIDNAPORE MEDICAL COLLEGE AND HOSPITAL VIDYASAGAR ROAD MIDNAPORE PASCHIM MIDNAPORE

Medinipur
WEST BENGAL
721101
India 
Phone  9434474471  
Fax    
Email  debmalyamukherjee1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  RITA PAL 
Designation  PROFESSOR AND HOD DEPARTMENT OF ANAESTHESIOLOGY IPGMER 
Affiliation  PROFESSOR AND HOD DEPARTMENT OF ANAESTHESIOLOGY IPGMER 
Address  Department of Anaesthesiology IPGMER 244, Acharya Jagadish Chandra Bose Rd, Bhowanipore, Kolkata, West Bengal 700020

Kolkata
WEST BENGAL
700020
India 
Phone  9830418539  
Fax    
Email  ritapal1956@gmail.com  
 
Details of Contact Person
Public Query  
Name  ARUN KUMAR MANDI 
Designation  ASSISTANT PROFESSOR DEPARTMENT OF ANAESTHESIOLOGY  
Affiliation  MIDNAPORE MEDICAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF ANAESTHESIOLOGY MIDNAPORE MEDICAL COLLEGE AND HOSPITAL VIDYASAGAR ROAD MIDNAPORE PASCHIM MIDNAPORE

Medinipur
WEST BENGAL
721101
India 
Phone  8697633923  
Fax    
Email  mandiarunkr87@gmail.com  
 
Source of Monetary or Material Support  
OFFICE OF PRINCIPAL MIDNAPORE MEDICAL COLLEGE AND HOSPITAL 
 
Primary Sponsor  
Name  MIDNAPORE MEDICAL COLLEGE AND HOSPITAL 
Address  MIDNAPORE PASCHIM MIDNAPORE PIN 721101 
Type of Sponsor  Government 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 
DEBMALYA MUKHERJEE  MIDNAPORE MEDICAL COLLEGE AND HOSPITAL  DEPARTMENT OF ANAESTHESIOLOGY MIDNAPORE PASCHIM MIDNAPORE 721101
Medinipur
WEST BENGAL 		 9434474471

debmalyamukherjee1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE OF MMCH  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  SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK FOR POST OPERATIVE ANALGESIA IN UPPER LIMB SURGERY  SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK GIVEN WITH 19 ML OF 0.5 % BUPIVACAINE AND 1 ML OF DISTILLED WATER FOR POST OPERATIVE ANALGESIA IN UPPER LIMB SURGERY  
Intervention  SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK FOR POST OPERATIVE ANALGESIA IN UPPER LIMB SURGERY  SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK GIVEN WITH 19 ML OF 0.5 % BUPIVACAINE AND 1 ML OF PENTAZOCINE (30 MG) FOR POST OPERATIVE ANALGESIA IN UPPER LIMB SURGERY 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Age between 18-60 years
2. ASA grade 1 & 2
3. Elective upper limb Surgery under supraclavicular brachial plexus block
 
 
ExclusionCriteria 
Details  1. Patients with history of
Uncontrolled Diabetes-Mellitus
Uncontrolled Hypertension
Coagulopathy
Liver disease
Cardio pulmonary disease
Renal insufficiency or failure
Musculoskeletal disorder
Drug and alcohol abuse
2. Pregnant patients
3. BMI more than 30
4. Allergy to bupivacaine or pentazocine
5. Conversion to general anesthesia
7. Brachial plexus block failure
8. Difficult airway
9. Surgeries with intraoperative time more than 2 hours.
10. Patient who received analgesic in the pre operative phase (within effective time range of that particular drug)
11. Unwilling to participate
12. Serology positive (HIV1&2,Hbs ag,Anti HCV), & immunocompromised patients
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
We are expecting that 0.5% bupivacaine with pentazocine as an adjuvant will increase duration of sensory and motor blockade and will provide better analgesia than 0.5% bupivacaine alone   Patient’s hemodynamic profile (like BP, heart rate, oxygen saturation etc), pain , and adverse effects will be monitored at base line, just after giving block then every 15 minutes intra operatively and every hour postoperatively for 8 hours.
 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare the hemodynamic changes like Heart rate(HR), Systolic Blood Pressure(SBP),
Diastolic Blood Pressure(DBP),Mean Arterial Pressure(MAP) intra and post operatively
2. To compare the side effects of pentazocine in supra clavicular brachial plexus block
3. Patient’s satisfaction
4. Surgeon’s satisfaction
 		 Patient’s hemodynamic profile (like BP, heart rate, oxygen saturation etc), pain , and adverse effects will be monitored at base line, just after giving block then every 15 minutes intra operatively and every hour postoperatively for 8 hours.
 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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   N/A 
Date of First Enrollment (India)   15/07/2020 
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="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NO PUBLICATION YET 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

A prospective,randomised,double blinded comparative study between 0.5% bupivacaine and 0.5% bupivacaine with pentazocine as an adjuvant in supraclavicular brachial plexus block for post operative analgesia in upper limb surgery

Our objective is to compare the intraoperative effect , hemodynamic stability and post operative analgesia duration  and side effects between 0.5% bupivacaine and 0.5% bupivacaine with pentazocine as an adjuvent in supraclavicular brachial plexus block .

This is a hospital based, prospective, randomized, placebo-controlled, double blind, analytical  study on cohort of patients posted for elective upper limb surgery under supra clavicular brachial plexus block in general surgery and orthopedics operation theatre and PACU of Midnapore Medical College over the period of 18 months

We are expecting that 0.5% bupivacaine with pentazocine as an adjuvant will increase duration of sensory and motor blockade and will provide better analgesia than 0.5% bupivacaine alone on 70 patient posted for upper limb surgery .

 

 
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