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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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