| CTRI Number |
CTRI/2024/08/072932 [Registered on: 22/08/2024] Trial Registered Prospectively |
| Last Modified On: |
21/08/2024 |
| 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
|
Study of effect of an adjuvant to local anaesthetics in ultrasound guided supraclavicular brachial plexus block in upper limb surgeries |
|
Scientific Title of Study
|
A comparative evaluation of Magnesium sulphate as an adjuvant to bupivacaine with bupivacaine alone in ultrasound guided supraclavicular brachial plexus block in upper limb surgeries - A prospective 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 Prasad P B |
| Designation |
DNB student |
| Affiliation |
Shri Lal Bahadur Shastri Government Medical College and hospital |
| Address |
Anaesthesia department
RDH Room No.113
Shri Lal Bahadur Shastri Government Medical College and hospital
Nerchowk at Mandi
Himachal Pradesh
Mandi
HIMACHAL PRADESH
175021
India |
| Phone |
8248096157 |
| Fax |
|
| Email |
prasadpbguptha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasad P B |
| Designation |
DNB student |
| Affiliation |
Shri Lal Bahadur Shastri Government Medical College and hospital |
| Address |
Anaesthesia department
RDH Room No 113
Shri Lal Bahadur Shastri Government Medical College and hospital
Nerchowk at Mandi
Himachal Pradesh
HIMACHAL PRADESH
175021
India |
| Phone |
8248096157 |
| Fax |
|
| Email |
prasadpbguptha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prasad P B |
| Designation |
DNB student |
| Affiliation |
Shri Lal Bahadur Shastri Government Medical College and hospital |
| Address |
Anesthesia department
RDH Room No 113
Shri Lal Bahadur Shastri Government Medical College and hospital
Nerchowk at Mandi
Himachal Pradesh
HIMACHAL PRADESH
175021
India |
| Phone |
8248096157 |
| Fax |
|
| Email |
prasadpbguptha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Lal Bahadur Shastri Government Medical College and hospital
Mandi
Himachal Pradesh
INDIA
PIN 175021 |
|
|
Primary Sponsor
|
| Name |
Shri Lal Bahadur Shastri Govt medical college Department of Anaesthesiology |
| Address |
Shri Lal Bahadur Shastri Government Medical College and hospital
Mandi at Ner Chowk
Himachal Pradesh
INDIA
Pin 175021
Mandi
Himachal pradesh |
| 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 Vishawjeet Singh |
Shri Lal Bahadur Shastri Government Medical College and hospital |
6th floor
Department of anesthesia
Shri Lal Bahadur Shastri Government Medical College and hospital
Mandi
Himachal pradesh
175021
Mandi
HIMACHAL PRADESH |
9418002595
vish.001@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC SLBS Govt. Medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
GROUP A : Controll group
drug- bupivacaine + placebo (Normal saline)
|
Group A : 30 ml of 0.5% bupivacaine +0.5 ml Normal saline in supraclavicular brachial plexus block (perineural injection) |
| Intervention |
Group B : Intervention group
drug- Bupivacaine + magnesium sulphate |
Group B : 30ml of 0.5% bupivacaine + 0.5ml of 50% magnesium sulphate in supraclavicular brachial plexus block(perineural injection) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Graade I & II
Patient giving consent to participate in study
|
|
| ExclusionCriteria |
| Details |
ASA Grade III & IV
Patients with hypersensitivity to study drugs,
Local infection at the site of block,
Bleeding disorders, Coagulopathies, Cardiovascular diseases. Respiratory disorders, Renal impairment, Hepatic diseases, CNS diseases, Uncontrolled hypertension and diabetes |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the onset and duration of sensory and motor block in Group A ( Recieving bupivacaine alone) and compare it with Group B (recieving bupivacaine and magnesium sulphate) |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess and compare the hemodynamic changes in between group A and group B
To study complications if any |
1 year |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
01/09/2024 |
| 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
|
This study aims the effect of an adjuvant drug (Magnesium sulphate) in supraclavicular brachial plexus block in upper limb surgeries that would increase the duration of sensory and motor blockade and would give good postoperative analgesia Study about to start and completion in 1 year |