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CTRI Number  CTRI/2024/02/062429 [Registered on: 08/02/2024] Trial Registered Prospectively
Last Modified On: 23/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Verapamil as an adjunct to LA in usg guided supraclavicular brachial plexus block 
Scientific Title of Study   comparison of 0.5% bupivacine alone versus 0.5% bupivacaine with verapamil as an adjunct in ultra sound guided supraclavicular brachial plexus block 
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 ASHWIN KUMAR 
Designation  Post graduate trainee  
Affiliation  Srimanta Sankaradeva University of health science  
Address  Department of anaesthesiology and critical care, Silchar medical college and hospital ,Silchar, Assam
Guwahati
Kamrup
ASSAM
788014
India 
Phone  9006815204  
Fax    
Email  ashwin.ashiik.kumar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Suneeta Dutta  
Designation  Head of department and professor  
Affiliation  Silchar medical college and hospital  
Address  Department of anaesthesiology and critical care,Silchar medical college and hospital

Cachar
ASSAM
788014
India 
Phone  9435074110  
Fax    
Email  drsuneetadutta@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Suneeta Dutta  
Designation  Head of department and professor  
Affiliation  Silchar medical college and hospital  
Address  Department of anaesthesiology and critical care,Silchar medical college and hospital

Cachar
ASSAM
788014
India 
Phone  9435074110  
Fax    
Email  drsuneetadutta@gmail.com  
 
Source of Monetary or Material Support  
Silchar medical college and hospital , Silchar,cachar ,,788014 
 
Primary Sponsor  
Name  Silchar medical college and hospital  
Address  Department of anaesthesiology and critical care,Silchar medical college and hospital, cachar, Assam  
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 
Dr Ashwin Kumar   Silchar medical college and hospital   Operation theatre room of orthopaedics, department of orthopaedics.
Cachar
ASSAM 
9006815204

ashwin.ashiik.kumar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee of Silchar medical college and hospital   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  bupivacaine in usg guided brachial plexus block   The study aims to compare verapamil as an adjunct to bupivacaine in terms of onset and duration of sensory and motor block , hemodyanmic parameters like heart rate, blood pressure , spo2 ,and time to give first rescue analgesia . These parameters will be evaluated up to 6 hours. The intervention will be done using ultrasound machine to achieve the brachial plexus block.the study will also take into consideration of side effects if any that can result due to technique of drug delivery and side effect by drug verapamil.  
Comparator Agent  Verapamil as an adjunct to bupivacaine in usg guided supraclavicular brachial plexus block   The study aims to compare verapamil as an adjunct to bupivacaine in terms of onset and duration of sensory and motor block, hemodynamic parameters like heart rate, blood pressure, spO2 and time to give first rescue analgesia. These parameters will be evaluated up to 6 hours.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA grade 1 and 2
Elective upper limb surgeries
Patients of either sex aged 18 to 60 years
Total body weight between 45 to 80 kgs 
 
ExclusionCriteria 
Details  Allergy to bupivacaine and verapamil
Pregnant
Patient with chest deformity and clavicle fracture
Patient with coagulopathies
Pateint with pre existing motor and sensory deficiet
Active infection at the site of the injection  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Onset and duration of sensory and motor block , hemodyanmic stabile like heart rate, blood pressure,spo2, time for first rescue analgesia and side effects if any  Outcomes mentioned above will be measured at o mins , 15 mins, 30 mins , 45 mins , 1 hrs , 2 hrs , 4 hrs and finally at 6 hrs of block 
 
Secondary Outcome  
Outcome  TimePoints 
Time taken to perform block under usg guidance, to evaluate block performance and side effects due to technique like pneumothorax, Horner syndrome etc  Up to 24hrs 
 
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 
Date of First Enrollment (India)   15/02/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Brachial Plexus block is a good alternative to general anesthesia for upper limb surgery. This type of anaesthesia mainly helps to achieve ideal operating conditions by producing muscular relaxation, maintaining stable intraoperative hemodynamic condition, sympathetic block and also reduces postoperative pain, vasospasm and oedema. This also avoids the unwanted effects  of general anaesthesia and the stress of upper airway instrumentation.

Regional nerve blocks are based on the concept that pain is conveyed by nerve fibres, which can be interrupted anywhere along their pathway. For upper limb Surgeries, Brachial plexus block is the preferred regional anaesthesia technique. Brachial plexus block at the supraclavicular level offers dense anaesthesia for surgical procedures at or distal to the elbow.

In the last decade image guided peripheral nerve block has become the norm for the anesthesiologist at the forefront of regional anaesthesia. Out of those dominant methods of imaging is the Ultrasonography. Ultrasound can determine the size, depth, and exact location of the brachial plexus and its neighboring structures. Real-time ultrasound imaging can help to guide the block needle to reach target nerves with fewer attempts. Under visual guidance, needle movement is purposeful and based on constant image feedback, thus avoiding nerve localization by trial and error.

Local anaesthetic administered for regional nerve blocks are utilized in providing post- operative pain relief in many surgical procedures by blocking signal traffic to the dorsal horn. Various local anaesthetics alone or in combination with different adjuvants have been tried to prolong the duration of postoperative analgesia for a long time but have met with limited success. Bupivacaine is a well‑established long‑acting regional anaesthetic, which like all amide anaesthetics has been associated with cardiotoxicity when used in high concentration or when accidentally administered intravascularly.

Now the challenge remains with the anaesthesiologists to prolong the duration of analgesia while minimizing adverse effects with singleshot brachial plexus block. Significant prolongation of brachial plexus analgesia is ideally accomplished with placement of continuous catheters. For moderate prolongation of analgesia (<24 h), various adjuvant drugs can be admixed with local anaesthetic. Therefore, investigators have tried mixing local anaesthetic with adjuvant drugs to prolong anaesthesia with nerve block. Adjuvants including epinephrine, clonidine, opioids, ketamine and midazolam have met but with limited success.

              Verapamil, initially developed as a coronary vasodilator, is a phenylalkyamine type of calcium channel blocker. It selectively inhibits calcium influx through cellular membranes. . Calcium plays an important role in pain formation. Verapamil (calcium channel blocker) has been shown to have potent local anesthetic activity, reflecting inhibition of fast sodium channels. Other minor mechanism includes alpha-adrenergic blocking effect and in the neurons they block the neurotransmitter release.

              This study will be conducted to compare Bupivacaine alone and Bupivacaine with verapamil in supraclavicular brachial plexus block with ultra sound guided technique.


 
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