| CTRI Number |
CTRI/2025/11/097913 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
24/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of different doses of Magnesium Sulphate for pain relief in old patients after knee replacement |
|
Scientific Title of Study
|
Effect of different doses of Magnesium Sulphate in adductor canal block on postoperative pain in elderly patients undergoing Total knee arthroplasty: a randomized prospective 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 |
Neha Garg |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute Of Medical Sciences, Delhi, India |
| Address |
Department of anesthesia, pain medicine and critical care, Ansari Nagar
AIIMS
South
DELHI
110029
India |
| Phone |
09711896795 |
| Fax |
|
| Email |
nehagargpgimer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neha Garg |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute Of Medical Sciences, Delhi, India |
| Address |
Department of anesthesia, pain medicine and critical care, Ansari Nagar
AIIMS
South
DELHI
110029
India |
| Phone |
09711896795 |
| Fax |
|
| Email |
nehagargpgimer@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neha Garg |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute Of Medical Sciences, Delhi, India |
| Address |
Department of anesthesia, pain medicine and critical care, Ansari Nagar
AIIMS
South
DELHI
110029
India |
| Phone |
09711896795 |
| Fax |
|
| Email |
nehagargpgimer@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sceinces, Delhi, India- 110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS DELHI |
| Address |
As it is a routine procedure for providing block for pian relief in the postoperative period, no additional cost will be incurred |
| 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 |
| Neha Garg |
AIIMS, DELHI |
NCA 5 TH FLOOR OPERATION THETARE, AIIMS, DELHI-110029
South
DELHI |
09711896795
nehagargpgimer@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Magnesium Sulphate 1 g |
Magnesium Sulphate 1 mg in 0.2 % ropivaciane 20 ml for adductor canal block once after surgey |
| Comparator Agent |
Magnesium Sulphate 125 mg |
Magnesium Sulphate 125 mg in addition to 20 ml of .2 % ropivacaine in Adductor canal block once after surgery |
| Intervention |
Magnesium Sulphate 250 mg |
Magnesium Sulphate 250 mg in addition to 20 ml of .2 % ropivacaine in Adductor canal block once after surgery |
| Intervention |
Magnesium Sulphate 500 mg |
Magnesium Sulphate 500 mg in addition to 20 ml of .2 % ropivacaine in Adductor canal block once after surgery |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA physical status I–III
2. Scheduled for elective unilateral primary TKA
3. Able to understand pain scoring and give informed consent
|
|
| ExclusionCriteria |
| Details |
1. Allergy to study drugs
2. Chronic opioid use or neuropathic pain
3. Neuromuscular disorders
4. Local infection at injection site
5. Severe hepatic/renal dysfunction or cognitive impairment
|
|
|
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 time to first breakthrough pain (time to first request for rescue analgesia) in the different doses of Magnesium Sulphate (125 mg, 250 mg, 500 mg, and 1 g) as an adjuvant to ropivacaine in Adductor canal block |
2,4,6,12,24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• VAS scores (0–10) at rest and during 45° knee flexion at 2, 6, 12, 24, and 48 hours postoperatively
• Total opioid consumption 0.5 mg /kg fentanyl in first 48 hours
• Quadriceps strength using Handheld dynamometer
• Adverse effects: nausea, vomiting, sedation, hypotension, bradycardia, motor weakness
|
2,4,6,12,24 hours |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
07/12/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The knee replacement patients have severe postoperative pain and need good analgesia, multimodal analgesia is required. Proving block would help them a lot. Adding magnesium in the block would prolong the analgesia but dose is not defined in any of the studies. Thus, we want to compare the different doses of magnesium which prolong the effect of block with minimal side effects. |