| 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
|
|
|
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
|
|
|
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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