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CTRI Number  CTRI/2023/04/051983 [Registered on: 26/04/2023] Trial Registered Prospectively
Last Modified On: 22/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A clinical trial to study the effect and safety of magnesium sulphate and dexmedetomidine in ultrasound guided transversus abdominus plane (TAP) block for postoperative analgesia after Caesarean section. 
Scientific Title of Study   Comparison of efficacy and safety of magnesium sulphate and dexmedetomidine in ultrasound guided transversus abdominus plane (TAP) block for postoperative analgesia after Caesarean section:A randomised ,double blind ,non inferiority study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vijeta Bajpai 
Designation  Assistant Professor Department of Anaesthesia 
Affiliation  All India Institute of Medical Sciences Gorakhpur 
Address  Department of Anaesthesiology Pain Medicine & Critical care AIIMS Gorakhpur
Flat no 203 ,Kadambini heights Apartment ,Taramandal Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India 
Phone  9918724600  
Fax    
Email  drvijeta86gsvm@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vijeta Bajpai 
Designation  Assistant Professor Department of Anaesthesia 
Affiliation  All India Institute of Medical Sciences Gorakhpur 
Address  Department of Anaesthesiology Pain Medicine & Critical care AIIMS Gorakhpur
Flat no 203,Kadambini Heights Apartment Taramandal Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India 
Phone  9918724600  
Fax    
Email  drvijeta86gsvm@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vijeta Bajpai 
Designation  Assistant Professor Department of Anaesthesia 
Affiliation  All India Institute of Medical Sciences Gorakhpur 
Address  Department of Anaesthesiology Pain Medicine & Critical care AIIMS Gorakhpur
Flat no 203,Kadambini Heights Apartment Taramandal Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India 
Phone  9918724600  
Fax    
Email  drvijeta86gsvm@gmail.com  
 
Source of Monetary or Material Support  
not applicable 
 
Primary Sponsor  
Name  DrVijeta Bajpai 
Address  Assistant Professor, Department of Anaesthesiology, Pain medicine &Critical Care All India Institute of Medical Sciences, Gorakhpur Contact no -9918724600 Email id- drvijeta86gsvm@gmail.com  
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
none  Not applicable  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vijeta Bajpai  All India Institute of Medical Sciences,Gorakhpur  Department of Anaesthesiology Pain Medicine & Critical Care ,Inpatient Department ,Kunraghat ,Gorakhpur,273008 Gorakhpur UTTAR PRADESH
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: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group DB  Patients will receive 20 ml 0.25% Bupivacaine + 0.5 mcg/kg Dexmedetomidine (mixed in 2 ml Normal saline) on each side. Immediately after completion of Surgery. 
Intervention  Group MB   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. 
 
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 non-inferiority of the mean duration of analgesia in patients who received magnesium sulphate and Dexmedetomidine as an adjuvant with bupivacaine in ultrasound guided Transversus Abdominus Plane (TAP) block for postoperative analgesia following Caesarean delivery  0-24 hours post operative period 
 
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. 		 0-24 hour post operative period 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   13/05/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   none yet  
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 (Others) -  Individual de-identified participant data will be shared in supplementary file of published manuscript

  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 identiļ¬ed 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 Magnesium sulphate or Dexmedetomidine with Bupivacaine in ultrasound guided Transversus Abdominus Plane (TAP) block for postoperative analgesia following Cesarean delivery  in 90  patients admitted at AIIMS Gorakhpur for elective or  emergency Cesarean delivery . The primary outcome measures will be to assess non-inferiority of the mean duration of analgesia in patients who received magnesium sulphate and Dexmedetomidine as an adjuvant with bupivacaine in ultrasound guided Transversus Abdominus Plane (TAP) block for postoperative analgesia following Caesarean delivery. Secondary

outcomes are 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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