| CTRI Number |
CTRI/2025/11/098066 [Registered on: 25/11/2025] Trial Registered Prospectively |
| Last Modified On: |
24/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study to compare the Effect of Dexamethasone Versus Dexmedetomidine as an additive to Ropivacaine in Transversus Abdominis Plane Block for Postoperative Analgesia in Patients undergoing Caesarean Section under Spinal Anaesthesia |
|
Scientific Title of Study
|
Efficacy and Safety of Dexamethasone Versus Dexmedetomidine as an adjuvant to Ropivacine in Transversus Abdominis Plane Block for Postoperative Analgesia in Patients undergoing Caesarean Section undergoing Spinal Anaesthesia - A Comparative 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 |
Tony Francis |
| Designation |
Junior Resident |
| Affiliation |
MGM Medical College and Hospital |
| Address |
Department of Anaesthesia, Medical College and Hospital, N6, CIDCO, Chhatrapati Sambhajinagar
Maharashtra
431003
India
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9961660655 |
| Fax |
|
| Email |
tonyf1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradnya Joshi |
| Designation |
Professor |
| Affiliation |
MGM Medical College and Hospital |
| Address |
Department of Anaesthesia, Medical College and Hospital, N6, CIDCO, Chhatrapati Sambhajinagar
Maharashtra
431003
India
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9823752665 |
| Fax |
|
| Email |
joshispradnya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradnya Joshi |
| Designation |
Professor |
| Affiliation |
MGM Medical College and Hospital |
| Address |
Department of Anaesthesia, Medical College and Hospital, N6, CIDCO, Chhatrapati Sambhajinagar
Maharashtra
431003
India
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9823752665 |
| Fax |
|
| Email |
joshispradnya@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Medical College and Hospital, N6, CIDCO, Chhatrapati Sambhajinagar, 431003, Maharashtra |
|
|
Primary Sponsor
|
| Name |
MGM Medical College and Hospital |
| Address |
Department of Anaesthesia, MGM Medical College and Hospital, N6, CIDCO, Chhatrapati Sambhajinagar, 431003, Maharashtra |
| 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 Tony Francis |
MGM Medical College and Hospital |
OT 1 and 2, Postop Recovery Room, OT Complex and Department of Anaesthesia, MGM Medical College and Hospital, N6, CIDCO, 431003, Maharashtra
Aurangabad
MAHARASHTRA |
9961660655
tonyf1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGM Ethics Committee for Research on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Transversus Abdominis Plane block using Inj Ropivacaine with Inj Dexamethasone |
To administer Transversus Abdominis Plane block using Inj Ropivacaine 0.2% 40ml with Inj Dexamethasone 8mg 2ml for Postop analgesia in Post Caeserian Section patients and parameters are monitored for a period of 24 hours. |
| Comparator Agent |
Transversus Abdominis Plane block using Inj Ropivacaine with Inj Dexmedetomidine |
To administer Transversus Abdominis Plane block using Inj Ropivacaine 0.2% 40ml with Inj Dexmedetomidine 0.5mcg/kg diluted to 2ml for Postop analgesia in Post Caeserian Section patients and parameters are monitored for a period of 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Patients undergoing lower segment caeserian section procedure under spinal anaesthesia will be included in the study. Weight 55-90 kg and Patients graded ASA 1 and ASA 2. |
|
| ExclusionCriteria |
| Details |
Patients with pre-existing bradycardia and conducting blocks, on beta adrenergic blockers, diabetes mellitus, morbid obesity, allergy to study drugs, patients whose plan of anaesthesia gets converted to general anaesthesia. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of postoperative analgesia, Total VAS score in 24 hours, Number of rescue analgesia requested in the first 24 hours |
To study and compare Duration of postoperative analgesia, Total VAS score in 24 hours, Number of rescue analgesia requested in the first 24 hours among the two study groups. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study & compare hemodynamic parameters, Ramsay sedation score, side effects like bradycardia, hypotension, nausea & vomiting |
To study & compare hemodynamic parameters, Ramsay sedation score, side effects like bradycardia, hypotension, nausea & vomiting over time periods - 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
14/01/2026 |
| 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 Yet Recruiting |
| 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
|
. |