| CTRI Number |
CTRI/2026/03/106474 [Registered on: 18/03/2026] Trial Registered Prospectively |
| Last Modified On: |
17/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
In this study, you will be assigned to either group A receiving ropivacaine + dexamethasone mixture or group B receiving ropivacaine + magnesium sulphate mixture for ultrasound guided brachial plexus block under general anaesthesia. |
|
Scientific Title of Study
|
Comparison of Magnesium sulphate and Dexamethasone as adjuvants to Ropivacaine in ultrasound guided brachial plexus block for postoperative analgesia in patients undergoing upperlimb surgeries
A randomised controlled trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jishina Issac |
| Designation |
PG resident |
| Affiliation |
MOSC medical college kolenchery |
| Address |
Department of Anesthesia, MOSC medical college, kolenchery
Ernakulam
KERALA
682311
India |
| Phone |
7306985980 |
| Fax |
|
| Email |
jishina.96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunitha K Zachariah |
| Designation |
Professor |
| Affiliation |
MOSC medical college kolenchery |
| Address |
Department of Anesthesia, MOSC medical college, kolenchery
Ernakulam
KERALA
682311
India |
| Phone |
9656277614 |
| Fax |
|
| Email |
sunutg97@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Jishina Issac |
| Designation |
PG resident |
| Affiliation |
MOSC medical college kolenchery |
| Address |
Department of Anesthesia, MOSC medical college, kolenchery
Ernakulam
KERALA
682311
India |
| Phone |
7306985980 |
| Fax |
|
| Email |
jishina.96@gmail.com |
|
|
Source of Monetary or Material Support
|
| MOSC medical college kolenchery, Ernakulam 682311 |
|
|
Primary Sponsor
|
| Name |
MOSC MEDICAL COLLEGE |
| Address |
Mosc medical college Kolenchery ernakulam 682311 |
| Type of Sponsor |
Private 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 Jishina Issac |
MOSC medical college hospital , kolenchery |
Department of Anesthesia
Ernakulam
KERALA |
07306985980
jishina.96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 |
Dexamethasone and ropivacaine |
Brachial plexus
block will be given under strict aseptic precaution and under ultrasound guidance. A mixture of 20 ml of
0.75% ropivacaine + 4mg dexamethasone(1ml) will be given to group RD |
| Comparator Agent |
Magnesium sulphate and Ropivacaine |
Brachial plexus
block will be given under strict aseptic precaution and under ultrasound guidance. A mixture of 20ml of 0.75%
ropivacaine + 250mg Magnesium sulphate (1ml) will be given to group RM |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Age: 18 -70 years 2. ASA physical status I and II patients 3. Body mass index (BMI) of 18-30 kg/m2 4. Patients undergoing elective upper limb surgeries under general anaesthesia with brachial plexus block. |
|
| ExclusionCriteria |
| Details |
1. Patient Refusal 2. Allergy to local anesthetic 3. Altered coagulation profile 4. Infection at site of injection 5. Failure of block |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of postoperative analgesia of ropivacaine and magnesium sulphate with ropivacaine and dexamethasone in brachial plexus blocks using numerical rating scale(NRS) for patients undergoing elective upper limb surgeries under general anaesthesia. |
Patient will be assessed for postoperative analgesia using numerical rating scale every 4th hourly for 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the total requirement of analgesics over 24 hour period postoperatively in patients undergoing upper limb surgeries under general anaesthesia with brachial plexus block using magnesium sulphate & dexamethasone as adjuvants to ropivacaine |
Every 4th hourly for 24 hours |
| To compare the pain score at 4 hour intervals postoperatively in patients undergoing elective upper limb surgeries under general anaesthesia with brachial plexus block using magnesium sulphate & dexamethasone as adjuvants to ropivacaine |
Every 4th hourly for 24 hours |
| To compare the various hemodynamic parameters in patients undergoing elective upper limb surgeries under general anaesthesia with brachial plexus block using magnesium sulphate & dexamethasone as adjuvants to ropivacaine |
Every 4th hourly for 24 hours |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
28/03/2026 |
| 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
|
To compare the duration of postoperative analgesia with 0.75% ropivacaine (20ml) and magnesium sulphate 250mg (1ml) versus 0.75%ropivacaine (20ml)and dexamethasone 4mg (1ml) in ultrasound guided brachial plexus blocks in patients undergoing elective upper limb surgeries under general anaesthesia and to compare the pain score and total requirement of analgesics over 24 hours postoperatively. Duration of analgesia will be calculated from the time of administration of the block to the time of rescue analgesia. Pain score will be calculated with the help of numerical rating scale (NRS) and when the patient has a pain score >/=3, analgesic will be started with paracetamol at a dose of 15mg/kg 8th hourly. Pain score will be assessed every 4th hourly. If the pain does not subside, tramadol 100mg will be added and at the end of 24 hours total analgesic requirement is calculated |