| 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
|
|
|
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
|
|
|
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 |
|
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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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