| CTRI Number |
CTRI/2024/04/065553 [Registered on: 12/04/2024] Trial Registered Prospectively |
| Last Modified On: |
07/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Preemptive versus Postoperative USG TAP (Transversus Abdominis Plane) block for postoperative Laparoscopic Cholecystectomy pain |
|
Scientific Title of Study
|
A comparison of effect of preemptive versus postoperative use of ultrasound guided bilateral transversus abdominis plane block (TAP) on pain relief after laparoscopic cholecystectomy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhupathi Manohar Sai Gopi Krishna |
| Designation |
Jr.Resident |
| Affiliation |
Rangaraya Medical College, Kakinada |
| Address |
Department of Anaesthesiology, Government General Hospital, Kakinada, East Godavari
East Godavari
ANDHRA PRADESH
533001
India |
| Phone |
6304591081 |
| Fax |
|
| Email |
krish.bhupathi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Yerramsetti Atchyuth Ramaiah |
| Designation |
Associate Professor |
| Affiliation |
Rangaraya Medical College, Kakinada |
| Address |
Department of Anaesthesiology, Government General Hospital, Kakinada, East Godavari
East Godavari
ANDHRA PRADESH
533001
India |
| Phone |
9949924203 |
| Fax |
|
| Email |
yerramsetti.atchyuth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhupathi Manohar Sai Gopi Krishna |
| Designation |
Jr.Resident |
| Affiliation |
Rangaraya Medical College, Kakinada |
| Address |
Department of Anaesthesiology, Government General Hospital, Kakinada, East Godavari
East Godavari
ANDHRA PRADESH
533001
India |
| Phone |
6304591081 |
| Fax |
|
| Email |
krish.bhupathi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Rangaraya Medical College, Kakinada, East Godavari - 533001 |
|
|
Primary Sponsor
|
| Name |
Bhupathi Manohar Sai Gopi Krishna |
| Address |
Department of Anaesthesia, Rangaraya Medical College, Kakinada |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DrManohar Bhupathi |
Government General Hospital, Kakinada |
Surgery Operation Theatre Complex, Theatre No.3, Department of Anaesthesiology, Rangaraya Medical College, Kakinada, East Godavari District, Andhra Pradesh.
533001
East Godavari
ANDHRA PRADESH |
6304591081
krish.bhupathi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RANGARAYA MEDICAL COLLEGE INSTITUTIONAL ETHICS COMMITTEE CELL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Post-operative Transversus Abdominis Plane Block |
20ml of 0.25% Ropivacaine given bilaterally |
| Intervention |
Preemptive Transversus Abdominis Plane block |
20ml of 0.25% Ropivacaine given bilaterally. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status of 1 and 2 according to American Society of Anesthesiologists Classification |
|
| ExclusionCriteria |
| Details |
Emergency Cholecystectomy
History of opioid dependence or tolerance
Conversion of Laparoscopic to Open Cholecystectomy
Unable to consent
History of allergy to ROPIVACAINE
Body Mass Index > 35
Coagulopathy
Uncontrolled intraoperative bleeding |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analog Scale for Pain Assessment (1-10)
0-No Pain
10 - Severe Pain |
0min
1hour
2hour
4hour
6hour
8hour
12hour
14hour
16hour
18hour
20hour
22hour
24hour
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluate the need for rescue analgesia |
0min
1hour
2hour
4hour
6hour
8hour
12hour
14hour
16hour
18hour
20hour
22hour
24hour
|
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2024 |
| Date of Study Completion (India) |
01/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Transversus abdominis plane (TAP) block is an effective approach for Post-operative pain control after Laparoscopic Cholecystectomy surgeries.Several studies have demonstrated the efficacy of the block in reducing postoperative pain scores, but fewer studies have been conducted on the timing of administration of the block.
My study aimed at comparison of effect of preemptive versus postoperative use of ultrasoundâ€guided bilateral TAP block on pain relief after laparoscopic cholecystectomy. |