| CTRI Number |
CTRI/2025/02/081405 [Registered on: 27/02/2025] Trial Registered Prospectively |
| Last Modified On: |
22/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Magnesium sulphate as an adjuvant in upper limb nerve block using different doses |
|
Scientific Title of Study
|
Dose response of perineural magnesium sulphate in ultrasound guided
infraclavicular brachial plexus block– A randomized double-blind 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 Arun Parthasarathy |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesiology, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9600129686 |
| Fax |
|
| Email |
p.arun1991@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Parthasarathy |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesiology, Kasturba Medical College, Manipal
KARNATAKA
576104
India |
| Phone |
9600129686 |
| Fax |
|
| Email |
p.arun1991@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arun Parthasarathy |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesiology, Kasturba Medical College, Manipal
KARNATAKA
576104
India |
| Phone |
9600129686 |
| Fax |
|
| Email |
p.arun1991@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba medical college and Kasturba hospital, Manipal, Karnataka - 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Arun Parthasarathy |
| Address |
Department of Anaesthesiology, Kasturba medical college and
hospital, Manipal, Karnataka, India - 576104 |
| 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 Arun Parthasarathy |
Kasturba Medical College and Kasturba hospital |
Department of
Anaesthesiology,
Manipal, 576104
Udupi
KARNATAKA |
9600129686
p.arun1991@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC and KH Institutional Ethics Committee |
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 |
| Comparator Agent |
Magnesium sulphate 125mg |
All participants will receive ultrasound guided infraclavicular brachial plexus block. Participants in this group will receive 20ml of 0.5% bupivacaine plus 125 mg (0.25 ml) magnesium sulphate plus 0.75ml normal
saline. |
| Comparator Agent |
Magnesium sulphate 250 mg |
All participants will receive ultrasound guided infraclavicular brachial plexus block. Participants in this group will receive 20ml of 0.5% bupivacaine plus 250 mg (0.5 ml) magnesium sulphate plus 0.5ml normal saline. |
| Intervention |
Magnesium sulphate 500 mg |
All participants will receive ultrasound guided infraclavicular brachial plexus block. Participants in this group will receive 20ml of 0.5% bupivacaine plus 500 mg (1 ml) magnesium sulphate. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status I and II, Surgeries for upper limb below the elbow |
|
| ExclusionCriteria |
| Details |
Participant refusal
Absolute contraindications for the block
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of participants with at least 150 minutes increase in the duration of analgesia when compared to the other groups. |
Every 2 hours for 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the onset and duration of sensory block
To compare the onset and duration of motor block
To note side effects like nausea, vomiting, bradycardia and hypotension |
Every 5 minutes for the initial 30 minutes.
Every 2 hours for 24 hours |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/04/2025 |
| Date of Study Completion (India) |
28/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Regional anaesthesia is the choice of anaesthesia for procedures involving the upper limb as it provides effective post-operative pain relief. Brachial plexus block (BPB) has evolved over the years as an important weapon in the armamentarium of anaesthesiologists. Local anaesthetics alone might not provide prolonged pain relief after the surgery because of its limited duration of action. Adding adjuvant to local anaesthetic is one way to prolong the analgesia. Different adjuvants have their own pros and cons. Magnesium sulphate (MgSO4), being a N-methyl-D-aspartate (NMDA) antagonist is an adjuvant to local anaesthetic in central neuraxial block, peripheral nerve blocks and fascial plane blocks. MgSO4 has been known to prolong the duration of analgesia as well as shorten the onset time of block. Different doses of perineural MgSO4 (between 100mg and 250 mg) have been used in clinical practice in brachial plexus block to increase the duration of analgesia. Studies with dose beyond 250 mg have not been used in brachial plexus block. Hence, we planned to compare the doses 125 mg, 250 mg and 500 mg of magnesium sulphate as an additive in infraclavicular brachial plexus block.
The study was completed successfully. Recruitment and follow-up were completed as per protocol. Data analysis has been completed |