| CTRI Number |
CTRI/2025/03/082160 [Registered on: 11/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect and Tolerability of Magnesium on pain after operation |
|
Scientific Title of Study
|
Comparison of efficacy and safety of preoperative, intraoperative and postoperative Magnesium sulfate (MgSO4) in reducing post operative pain in patient undergoing spinal anesthesia- A prospective, randomized, 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 |
Shubha Singhal |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, Rajkot |
| Address |
Department of Pharmacology
Academic Block
4th Floor
AIIMS, Rajkot
Gujarat, India
Rajkot GUJARAT 360110 India |
| Phone |
09560372056 |
| Fax |
|
| Email |
drshubhasinghal@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Shubha Singhal |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, Rajkot |
| Address |
Department of Pharmacology
Academic Block
4th Floor
AIIMS, Rajkot
Gujarat, India
GUJARAT 360110 India |
| Phone |
09560372056 |
| Fax |
|
| Email |
drshubhasinghal@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Shubha Singhal |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, Rajkot |
| Address |
Department of Pharmacology
Academic Block
4th Floor
AIIMS, Rajkot
Gujarat, India
GUJARAT 360110 India |
| Phone |
09560372056 |
| Fax |
|
| Email |
drshubhasinghal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Shubha Singhal
Department of Pharmacology
Academic Block
4th Floor
AIIMS, Rajkot
Gujarat, India 360001 |
|
|
Primary Sponsor
|
| Name |
Dr Shubha Singhal |
| Address |
Department of Pharmacology
Academic Block
4th Floor
AIIMS, Rajkot
Gujarat, India 360001 |
| 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 Shubha Singhal |
AIIMS, Rajkot |
Department of Pharmacology
4th Floor, Academic block, AIIMS, Rajkot Rajkot GUJARAT |
09560372056
drshubhasinghal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,AIIMS, Rajkot |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S829||Unspecified fracture of lower leg, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Magnesium Sulphate |
Pre operative , intraoperative and post operative administration of MgSo4 different patients over the duration of 15 minutes undergoing spinal anesthesia |
| Comparator Agent |
Pre operative Magnesium Sulphate
Intraoperative Magnesium Sulphate
Post Operative Magnesium Sulphate |
Pre operative , intraoperative and post operative administration of MgSo4 in different patients over the duration of 15 minutes undergoing spinal anesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
2) American Society of Anesthesiologists physical status classification system I and II (healthy patient or patient with mild systemic disease)
3) Patient coming for lower limb surgery requiring spinal anesthesia
4) Patients stay for at least 24 hours postoperatively.
|
|
| ExclusionCriteria |
| Details |
1) Patients undergoing surgery other than lower limb surgery due to trauma
2) Patient requiring surgery under general anaesthesia
3) Known case of neuromuscular disease or heart block or respiratory diseases
4) Renal dysfunction
5) Patient on calcium channel blockers
6) Allergic to MgSO4
7) Pregnant female
8) Lactating mother
9) Any other contraindication for spinal anaesthesia.
|
|
|
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 |
| To evaluate the opioid consumption in post operative period (first 24 hours) in preoperative, intraoperative and post operative MgSO4 administration |
At 0, 2, 6, 12 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the safety and tolerability, the number of adverse effects |
At 0, 2, 6, 12 hour |
|
|
Target Sample Size
|
Total Sample Size="102" Sample Size from India="102"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
12/04/2025 |
| 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="2" Months="0" 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
|
Postoperative
pain is a significant factor that impacts the surgical outcome and course of
treatment. The major goal of postoperative pain management is to reduce the
dose of medications and consequently the incidence of side effects, while
ensuring sufficient pain relief. Postoperative pain relief leads to earlier
mobilization, shortened hospital staying, reduced hospital costs, and increased
patient satisfaction .
Opioids are the most
frequently used analgesics for postoperative pain. However, they have their own
limitations and adverse effects including constipation, pruritis, altered
mental state and respiratory depression. Hence, there is need of certain
adjuvant analgesics which reduce the requirement of opioids without
compromising the post operative pain relief and recovery
Magnesium (Mg) is a
positively charged divalent cation which has minimal side effects and has long
been utilized in medical practice as an anticonvulsant or antiarrhythmic drug . Being an NMDA receptor antagonist, magnesium
has the potential to be employed as an adjuvant analgesic. Furthermore, it also
disrupts the entry of calcium into the cell and produces central analgesic
action. At the peripheral level, it
inhibits the release of catecholamine from the sympathetic neurons, resulting
in a reduction of peripheral nociception and the stress reaction after surgery.
There are studies which
evaluate the role of magnesium as an adjuvant analgesic. Most of them were
carried out in patients who were undergoing surgery under general anaesthesia. Relatively few studies have been conducted on the
effects of magnesium sulphate administration during spinal anaesthesia [1,
2,7]. Furthermore, most of
them evaluated the role of perioperative IV magnesium in reducing post
operative pain. To the best of our knowledge, none of the studies evaluate the
efficacy of IV MgSO4 in intraoperative and post operative period under spinal
anaesthesia. Peng at el also confirmed in his metanalysis that there is need of
future research that evaluates the effect of time of delivery of IV magnesium
sulphate on analgesia Hence, the current study is planned to
evaluate and compare the efficacy and safety of preoperative, intraoperative
and post operative IV magnesium sulphate under spinal anesthesia. |