| CTRI Number |
CTRI/2020/11/029150 [Registered on: 17/11/2020] Trial Registered Prospectively |
| Last Modified On: |
22/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Ultrasound Guided Transversus abdominis plane Block for Postoperative Analgesia with Ropivacaine and Dexamethasone versus Ropivacaine and mopphine as additive in Lower Abdominal Surgeries |
|
Scientific Title of Study
|
Randomized control double
blind comparative study of Ultrasound Guided Transversus Abdominis Plane
Block with 0.25% Ropivacaine with Dexamethasone vs Morphine as additives for
post operative analgesia in patients undergoing lower abdominal surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AJAYRAKESHVARMA CHENNAREDDY |
| Designation |
Anaesthesia Resident |
| Affiliation |
Department Of Anesthesia,SRM Medical College and Research Center |
| Address |
Department of Anaesthesia SRM Medical college and Research Institute Kattankulathur Chennai Tamilnadu
SRM Medical college and Research Institute SRM Nagar Potheri kattankulathur 603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9492272543 |
| Fax |
|
| Email |
ajayrakeshvarma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sivarajan G |
| Designation |
Professor |
| Affiliation |
Department Of Anesthesia,SRM Medical College and Research Center |
| Address |
Department of Anaesthesia SRM Medical college and Research Institute Kattankulathur Chennai Tamilnadu
SRM Medical college and Research Institute SRM Nagar Potheri kattankulathur 603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9492272543 |
| Fax |
|
| Email |
gsivarajan26@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
AJAYRAKESHVARMA CHENNAREDDY |
| Designation |
Anaesthesia Resident |
| Affiliation |
Department Of Anesthesia,SRM Medical College and Research Center |
| Address |
Department of Anaesthesia SRM Medical college and Research Institute Kattankulathur Chennai Tamilnadu
SRM Medical college and Research Institute SRM Nagar Potheri kattankulathur 603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9492272543 |
| Fax |
|
| Email |
ajayrakeshvarma@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM MEDICAL COLLEGE AND RESEARCH CENTRE |
|
|
Primary Sponsor
|
| Name |
SRM MEDICAL COLLEGE AND RESEARCH CENTRE |
| Address |
SRM MEDICAL COLLEGE AND RESEARCH CENTRE SRM NAGAR POTHERI KATTANKULATHUR |
| 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 |
| AJAYRAKESHVARMA CHENNAREDDY |
SRM MEDICAL COLLEGE AND RESEACH CENTRE |
SRM Medical college& Research Institute KATTANKULATHUR
Kancheepuram
TAMIL NADU |
9492272543
ajayrakeshvarma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical college hospital and research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, (2) ICD-10 Condition: K429||Umbilical hernia without obstruction or gangrene, (3) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.25% Ropivacaine with Dexamethasone Vs Morphine as additives for Postoperative Analgesia |
O.25% ropivacaine wih 4mg of dexamethasone eitherside compared with 0.25% ropivacaine with 2mg morphine either side for postoperative analgesia in lower abdominal surgeries |
| Intervention |
TRANSVERSUS ABDOMINIS PLANE BLOCK |
Ultrasound guided Transversus Abdominis Plane Block for Postoperative Analgesia in patients undergoing lower abdominal surgeries |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesia grade I or II
Patients coming for lower Abdominal surgeries |
|
| ExclusionCriteria |
| Details |
ASA grade III and IV
Patient refusal
Coagulopathy or anticoagulation treatment INR>1.5 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of Post Operative Analgesia |
From the End of the Surgery to 24 hours postoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Analgesic consumption in the postoperative period |
from the end of the surgery to 24 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/11/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
22/05/2022 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
ASA 1 and 2 Patients of Age group 18 to 60 years undergoing Lower abdominal surgeries will be given USG Guided Transversus Abdominis Plane Block with 20ml of 0.25% Ropivacaine with 4mg Dexamethasone and 2mg Morphine as additives either side for post operative analgesia in two different groups duration of postoperative analgesia and total analgesic consumption in 24 hours will be compared in between these two groups |