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CTRI Number  CTRI/2023/04/052058 [Registered on: 27/04/2023] Trial Registered Prospectively
Last Modified On: 22/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Preventive 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A clinical trial to compare two different doses of magnesium sulfate as an adjuvant to bupivacaine in transversus abdominis plane block for postoperative analgesia in caesarean section. 
Scientific Title of Study   A comparative evaluation of two different doses of magnesium sulfate as an adjuvant to bupivacaine in transversus abdominis plane block for postoperative analgesia in caesarean section: A randomized, double-blind, superiority trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrVijeta Bajpai 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences Gorakhpur 
Address  Department of Anaesthesiology, Pain Medicine &Critical Care All India Institute of Medical Sciences ,Gorakhpur ,Uttar Pradesh

Gorakhpur
UTTAR PRADESH
273008
India 
Phone  9918724600  
Fax    
Email  drvijeta86gsvm@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrVijeta Bajpai 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences Gorakhpur 
Address  Department of Anaesthesiology, Pain Medicine &Critical Care All India Institute of Medical Sciences,Gorakhpur

Gorakhpur
UTTAR PRADESH
273008
India 
Phone  9918724600  
Fax    
Email  drvijeta86gsvm@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrVijeta Bajpai 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences Gorakhpur 
Address  Department of Anaesthesiology, Pain Medicine &Critical Care All India Institute of Medical Sciences ,Gorakhpur ,Uttar Pradesh

Gorakhpur
UTTAR PRADESH
273008
India 
Phone  9918724600  
Fax    
Email  drvijeta86gsvm@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  DrVijeta Bajpai 
Address  Department of Anaesthesiology, Pain Medicine &Critical Care All India Institute of Medical Sciences, Gorakhpur  
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrVijeta Bajpai  All India Institute of Medical Sciences,Gorakhpur  Department of Anaesthesiology, Pain &Critical Care Medicine All India Institute of Medical Sciences, Gorakhpur
Gorakhpur
UTTAR PRADESH 		 9918724600

drvijeta86gsvm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee, All India Institute of Medical Sciences, Gorakhpur Uttar Pradesh, India-273008  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 1||Obstetrics, (2) ICD-10 Condition: O268||Other specified pregnancy relatedconditions,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  MgSO4-200 mg both side  Group A – Patients will receive 20 ml 0.25% Bupivacaine + 200 mg (0.4 ml of MgSO4 50 %) Magnesium sulphate +1.6 ml NS on each side Immediately after completion of Surgery  
Comparator Agent  MgSO4-500 mg both side  Group B- Patients will receive 20 ml 0.25% Bupivacaine + 500 mg (1 ml of MgSO4 50 %) Magnesium sulphate +1 ml NS on each side. Immediately after completion of Surgery  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1 18 - 35 years females belonging to the American Society of Anesthesiologists (ASA) Class I/II
2 Elective or Emergency LSCS under Subarachnoid block.
3 Normal bleeding profile.
4 No history of relevant drug allergy.
5 Patients willing to participate in the study. 
 
ExclusionCriteria 
Details  1 Age <18 and >35 years.
2 Patient refusal.
3 Significant cardiovascular disease, hepatic dysfunction or renal dysfunction
4 Coagulation abnormalities and Bleeding disorder
5 Infection in the intended intervention site
6 Patient on intravenous MgSO4
7 Eclamptic or preeclamptic patient 
 
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 assess superiority of the mean duration of analgesia in patients who received magnesium sulphate 500 mg as an adjuvant with bupivacaine as compared to magnesium sulphate 200 mg in ultrasound guided Transversus Abdominus Plane (TAP) block for postoperative analgesia following Caesarean delivery.
 		 post op -24 hours
 
 
Secondary Outcome  
Outcome  TimePoints 
1- To compare mean or median postoperative pain scores at rest and on coughing during first 24 hours (immediately after block, 30 min, 1 h, 2h, 4h, 8h, 12h and 24 h) following Caesarean delivery in both study groups
2- Total mean opioid consumption in first 24 hours following Caesarean delivery in both study groups
3- Haemodynamic parameters in both study groups
4- Satisfaction score in both study groups.
Safety outcome- Recording and reporting of adverse events(nausea, vomiting, prurutis, respiratory depression) will be collected.

 		 post op -24 hours 
 
Target Sample Size   Total Sample Size="112"
Sample Size from India="112" 
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)   18/05/2023 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drvijeta86gsvm@gmail.com].

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

This study is a randomized, double blind, parallel group, comparing 

the efficacy and safety of adding two different doses of  Magnesium sulphate with  Bupivacaine in ultrasound guided Transversus Abdominus Plane (TAP) block for postoperative analgesia following Cesarean delivery  in 112  patients admitted at AIIMS Gorakhpur for elective or  emergency Cesarean delivery . The primary outcome measures will be to assess superiority of the mean duration of analgesia in patients who received magnesium sulphate 500 mg as an adjuvant with bupivacaine as compared to magnesium sulphate 200 mg in ultrasound guided Transversus Abdominus Plane (TAP) block for postoperative analgesia following Caesarean delivery.Secondary outcome is to to compare mean or median postoperative pain scores at rest and on coughing during first 24 hours ,total mean opioid consumption in first 24 hours ,haemodynamic parameters and Satisfaction score in both study groups .Safety outcome will be  Recording and reporting of adverse events. 
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