| CTRI Number |
CTRI/2022/06/043277 [Registered on: 15/06/2022] Trial Registered Prospectively |
| Last Modified On: |
14/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to compare the effects of 0.5% Ropivacaine with 1mL (0.3mg) Buprenorphine versus 0.5% Ropivacaine with 1mL Normal saline while giving Supraclavicular brachial plexus block for upper limb orthopaedic surgeries. |
|
Scientific Title of Study
|
Buprenorphine as an adjuvant to 0.5% Ropivacaine for supraclavicular brachial plexus block: A randomized, prospective study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mrigakshi Sarma |
| Designation |
Post Graduate Trainee |
| Affiliation |
Gauhati Medical College and Hospital , Guwahati |
| Address |
Department of Anaesthesiology and Critical care
Gauhati Medical College and Hospital, Guwahati, Kamrup(Metro)
Kamrup
ASSAM
781032
India |
| Phone |
9707590744 |
| Fax |
|
| Email |
mrigakshisarma93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hiranya Kumar Saharia |
| Designation |
Associate Professor |
| Affiliation |
Gauhati Medical College and Hospital, Guwahati |
| Address |
Department of Anaesthesiology and Critical Care
Gauhati Medical College and Hospital, Guwahati, Kamrup(Metro)
Kamrup
ASSAM
781032
India |
| Phone |
9435087643 |
| Fax |
|
| Email |
sahariahiranya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hiranya Kumar Saharia |
| Designation |
Associate professor |
| Affiliation |
Gauhati Medical College and Hospital, Guwahati |
| Address |
Department of Anaesthesiology and Critical Care
Gauhati Medical, College and Hospital, Guwahati, Kamrup(Metro), Pin-781032
Kamrup
ASSAM
781032
India |
| Phone |
9435087643 |
| Fax |
|
| Email |
sahariahiranya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gauhati Medical College and
Hospital ,Guwahati ,Assam 781032 |
|
|
Primary Sponsor
|
| Name |
Mrigakshi Sarma |
| Address |
Post Graduate Student ,Department of Anaesthesiology and Critical Care, Gauhati Medical College and Hospital, Guwahati, Assam, Pin-781032 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Hiranya Kumar Saharia |
Associate professor, Department of Anaesthesiology and Critical Care, Gauhati Medical College and Hospital, Guwahati |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mrigakshi Sarma |
Gauhati Medical College and Hospital |
Department of Anaesthesiology and Critical Care, Gauhati Medical College and Hospital, Guwahati
Kamrup
ASSAM |
9707590744
mrigakshisarma93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Gauhati Medical College and Hospital, Guwahati |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection Buprenorphine with 0.5% Ropivacaine for Supraclavicular brachial plexus block. |
1ml(0.3mg) Buprenorphine to be added with 30 ml 0.5% Ropivacaine to be administered in the intervention group once for supraclavicular brachial plexus block and to be monitored for 24 hours post operatively. |
| Comparator Agent |
Injection Normal Saline 1ml with 30 ml 0.5% Ropivacaine. |
1ml Normal Saline with 30ml 0.5% Ropivacaine to be administered once in the comparator group for supraclavicular brachial plexus block and to be monitored for 24hours postoperatively. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. American Society of Anaesthesiology(ASA) physical status I and II.
2.Scheduled for elective Orthopaedic upper limb surgery under supraclavicular brachial plexus block.
3. Informed and written consent. |
|
| ExclusionCriteria |
| Details |
1.Unwilling patients.
2.Patients belonging to ASA physical status III or more.
3. Patients with known hypersensitivity to local anaesthetics.
4.Infection at the site of block.
5.Patients with known coagulopathy or patients on anticoagulation therapy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the duration of post operative analgesia by addition of injection buprenorphine to 0.5% Ropivacaine solution. |
After completion of the block to next 24hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Sensory block onset time.
2.Motor block onset time.
3.Post operative analgesia
4.Duration of motor block
5.Side effects and complications |
Sensory and Motor block onset time to be assessed for 30mins after completion of the block.
Motor block duration and post operative analgesia to be assessed for 24hours after completion of the block. |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
14/07/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Techniques of regional anaesthesia provide advantages over general anaesthesia. Supraclavicular brachial plexus block is the single most effective block for entire upper extremity and provides anaesthesia of all portions of upper extremity. To overcome the brief duration of action of local anaesthetics and to prolong intraoperative anaesthesia and postoperative analgesia many opioids have been tried with local anaesthetics.Ropivacaine, a local anaesthetic having wider safety margin, with decreased potential for central nervous system toxicity and cardiotoxicity, improves relative sensory and motor block profiles. Buprenorphine a semisynthetic opioid with longer duration of action cost effective and possess lesser degree of side effects such as sedation and respiratory depression.
REFERENCES 1.Jain N, Khare A, Khandelwal S, Mathur P, Singh M, Mathur V. Buprenorphine as an adjuvant to 0.5% Ropivacaine for ultrasound guided supraclavicular brachial plexus block: a randomized ,double-blind, prospective study. Indian J Pain[serial online] 2017[cited 2021Apr 1];31:112-8 2.Editorial Anaesthesia UK. Does regional anaesthesia improve outcome 2017. Available from http://www.frca.co.uk/article.aspx?articleid=100457.[Last cited on 2017 Apr15] 3.Brown DL. Brachial plexus anesthesia: an analysisof options. Yale J Biol Med. 1993 Sep-Oct;66(5):415-31 4.Patil S, Debata D, Doshi C, Vyas V, Sinha S. Effect of Buprenorphine as an adjunct with plain local anesthetic solution in supraclavicular brachial plexus block on quality and duration of postoperative analgesia. J Anaesthesiol Clin Pharmacol. 2015 Oct-Dec;31(4):496-500. 5.Paramaswamy R, Sabarinath S. Comparison of effect of 0.5% ropivacaine with fentanyl versus 0.5%ropivacaine with buprenorphine in axillary brachial plexus blocks for isolated hand and forearm injuries. Int J Med Anesthesiology 2020;3(1):16-22.. 6.Kuthiala G, Chaudhary G. Ropivacaine :A review of its pharmacology and clinical use. Indian J Anaesth 2011;55:104-10 7.Vadivelu N, Anwar M. Buprenorphine in postoperative pain management. Anesthesiol Clin. 2010 Dec; 28(4):601-9 |