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CTRI Number  CTRI/2025/04/084622 [Registered on: 11/04/2025] Trial Registered Prospectively
Last Modified On: 09/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Comparing the Effect of drug Magnesium Sulphate with Bupivacaine versus Dexmedetomidine with Bupivacaine versus plain Bupivacaine in nerve block to relive postoperative pain in LSCS patients. The main outcome of the study is to compare the duration and effect of pain relief. 
Scientific Title of Study   Comparing the effect of Magnesium sulphate with Bupivacaine versus Dexmedetomidine with Bupivacaine versus plain Bupivacaine in Transversus Abdominis Plain block for post operative analgesia in patient undergoing Elective Lower Segment Caesarean section 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Keerthiga M 
Designation  Assistant Professor 
Affiliation  Bhaarath medical college 
Address  Department of Anaesthesiology Bhaarath medical college Bhaarath university Agaram main road Selaiyur Chennai
Department of Anaesthesiology Bhaarath medical college Bhaarath university Agaram main road Selaiyur
Kancheepuram
TAMIL NADU
600073
India 
Phone  9600506041  
Fax    
Email  keerthigamohan3@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr keerthiga M 
Designation  Assistant Professor 
Affiliation  Bhaarath medical college 
Address  Department of Anaesthesiology Bhaarath medical college Bhaarath university Agaram main road Selaiyur Chennai
Department of Anaesthesiology Bhaarath medical college Bhaarath university Agaram main road Selaiyur Chennai
Kancheepuram
TAMIL NADU
600073
India 
Phone  9600506041  
Fax    
Email  keerthigamohan3@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr keerthiga M 
Designation  Assistant professor 
Affiliation  Bhaarath medical college 
Address  Department of Anaesthesiology Bhaarath medical college Bhaarath university Agaram main road Selaiyur Chennai
Department of Anaesthesiology Bhaarath medical college Bhaarath university Agaram main road Selaiyur Chennai
Kancheepuram
TAMIL NADU
600073
India 
Phone  9600506041  
Fax    
Email  keerthigamohan3@gmail.com  
 
Source of Monetary or Material Support  
Bhaarath medical college Agaram main road Selaiyur 600073 Chennai 
 
Primary Sponsor  
Name  Bhaarath medical college 
Address  DEPARTMENT OF ANAESTHESIOLOGY BHAARATH MEDICAL COLLEGE BHAARATH UNIVERSITY AGARAM MAIN ROAD SELAIYUR 
Type of Sponsor  Private 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 keerthiga M  Department of AnaesthesiaBhaarath medical college and hospital  Department of Anaesthesiology Bhaarath medical college Bhaarath university Agaram main road Selaiyur
Kancheepuram
TAMIL NADU 
9600506041

keerthigamohan3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bhaarath Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  transverse abdominis plane block  bupivacaine versus bupivacaine with dexmedetomidine versus bupivacaine with magnesium sulphate as an adjuvant for block 
Intervention  Transverse abdominis plane block  transverse abdominis plane block as an post operative analgesic agent for patients undergoing elective lscs 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  All patients undergoing Elective LSCS 
 
ExclusionCriteria 
Details  Patients Already On Magnesium Sulphate therapy
Patients With Coagulation Abnormality
Patients with infection at Injection site 
 
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 duration of analgesic effect
to compare the VAS score 
at 4 hours, 8 hours, 12 hours, 16th hour , 20 and 24 
 
Secondary Outcome  
Outcome  TimePoints 
Requirement of rescue analgesia for 24 hours post blockade  at 4 hours, 8 hours, 12 hours, 16th hour , 20 and 24 
 
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 3 
Date of First Enrollment (India)   21/04/2025 
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="0"
Months="6"
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   The objective of the study is to compare the effect of magnesium sulphate with bupivacaine versus dexmeditomidine with bupivacaine versus dexmeditomidine with bupivacaine versus plain bupivacaine in transversus abdominis plane block in patients undergoing elective LSCS .

Every patient will undergo pre anaesthetic assessment and a informed written consent will be obtained after explaining about the block. Patients will be kept NPO for 6 hours prior to surgery. On arrival in the operating room patient will be connected to the monitors such as electrocardiogram, pulse oximeter, and non-invasive blood pressure monitor. A 18 gauze peripheral venous cannula was inserted and intravenous fluid will be administered.

Patients will be monitored for hemodynamic parameters such as heart rate, systolic blood pressure and diastolic blood pressure and saturation in the above mentioned intervals.

     They will be randomly divided into three groups.

    Group B     -   30 patients will receive only 20 ml of  inj bupivacaine 0.25 %  on each side and 2 ml of normal saline.

   Group BM  -   30 patients will receive 20 ml of  inj bupivacaine 0.25 %  on each side and 0.5 ml of normal saline and 1.5 ml  

                            of   Magnesium sulphate ( 150 mg )

  GROUP BD  -  30 patients will receive 20 ml of  inj bupivacaine 0.25 %  on each side and 2ml of dexmeditomidine

(1       mcg/kg )

Under aseptic precautions at the level of L 3 – L 4 or L4 – L5 spinal anaesthesia will be given. Inj bupivacaine 0.5 % heavy 2 ml with fentanyl as adjuvant will be used for spinal anaesthesia. Post-surgery patients will receive bilateral TAP block under USG guidance .Lateral approach for TAP block will be done.

Post procedure duration of pain free period, intensity of pain using VAS score will be monitored at intervals of 4hours, 8 hours, 12 hours, 16hours and 24 hours. Need for rescue analgesia will be monitored in the above mentioned intervals. If the need of rescue analgesia is only inj.paracetamol 1g within 24 hrs post-surgery it will be scored as 1, if it is 2g within 24 hours it will be scored as 2, and if more than 3g within 24 hours it will be scored as 3. If patient is not responding to inj paracetamol1g and the time period has not crossed more than 8hours patient will receive inj.diclofenac 75mg IV as a pain relief medication and it will scored as 4. Patient requiring more than the mentioned analgesic dose for pain relief will be excluded from the study.

Patients will be monitored for hemodynamic parameters such as heart rate, systolic blood pressure and diastolic blood pressure and saturation in the above mentioned intervals.

     


 
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