| CTRI Number |
CTRI/2026/01/100111 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Optimizing Post-operative Pain Relief: A Comparison of two doses of Magnesium Sulphate with Ropivacaine in nerve blocks for orthopaedic Arm Surgery. |
|
Scientific Title of Study
|
Comparison of Efficacy of different doses of Magnesium Sulphate as an Adjuvant with Ropivacaine in Ultrasound 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 Bhanuprakash A |
| Designation |
Post graduate |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Anaesthesia, Bangalore Medical College and Research institute, Fort, Krishna Rajendra Road, Kalasipalya, Bengaluru, Karnataka.
Bangalore
KARNATAKA
560002
India |
| Phone |
7204448480 |
| Fax |
|
| Email |
bhanuprakasha004@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bindu |
| Designation |
Assistant Professor |
| Affiliation |
Bangalore Medical College and Research institute |
| Address |
Department of Anaesthesia, Bangalore Medical College and Research institute, Fort, Krishna Rajendra Road, Kalasipalya, Bengaluru, Karnataka.
Bangalore
KARNATAKA
560002
India |
| Phone |
9632035360 |
| Fax |
|
| Email |
drbindu82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhanuprakash A |
| Designation |
Post Graduate |
| Affiliation |
Bangalore Medical College and Research institute |
| Address |
Department of Anaesthesia, Bangalore Medical College and Research institute, Fort, Krishna Rajendra Road, Kalasipalya, Bengaluru, Karnataka.
Bangalore
KARNATAKA
560002
India |
| Phone |
7204448480 |
| Fax |
|
| Email |
bhanuprakasha004@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Bhanuprakash A |
| Address |
Department of Anaesthesia, Bangalore Medical College and Research institute, Fort, Krishna Rajendra Road, Kalasipalya, Bengaluru, Karnataka. PIN 560002 |
| Type of Sponsor |
Other [self] |
|
|
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 Bhanuprakash A |
Bangalore Medical College |
Department of Anaesthesia, Bangalore Medical College and Research institute, Fort, Krishna Rajendra Road, Kalasipalya, Bengaluru, Karnataka.
Bangalore
KARNATAKA |
7204448480
bhanuprakasha004@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Bangalore Medical College and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: PCS||, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Magnesium Sulphate |
250mg vs 500mg |
| Intervention |
Ropivacaine |
0.75% 19ml, 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient willing to provide informed written consent
2) ASA physical status grade 1 and 2
3) Patients undergoing Elective Orthopaedic upper limb surgeries under Supraclavicular Brachial Plexus Block. |
|
| ExclusionCriteria |
| Details |
1)Coagulation or bleeding disorders, Uncontrolled systemic diseases.
2)Local site infection
3)Any nerve injury/ neuropraxia/ paralysis
4)History of hypersensitivity to Ropivacaine
5)Cognitive or psychiatric disturbances.
6)Pregnant women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the effect of MgSO4 in two doses (250 mg and 500 mg) on the
duration of analgesia as an adjuvant to Ropivacaine in USG-guided
supraclavicular BPB. |
at 0hrs, 2hrs, 4hrs, 6hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare onset of sensory and motor blockade.
To assess the duration of sensory and motor blockade.
To compare hemodynamic profile.
To assess the adverse effects |
18 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
11/01/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 is a randomised, double blind, parallel group, comparing the analgesic efficacy of 250mg vs 50g of magnesium sulphate with ropivacaine 0.75% in 60 patients undergoing orthopeadic upperlimb surgeries under supraclavicular brachial plexus block for 1.5 years. |