| CTRI Number |
CTRI/2024/04/066051 [Registered on: 22/04/2024] Trial Registered Prospectively |
| Last Modified On: |
15/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to compare the effect of laparoscopic tranverse abdominis plane block with non TAP block in pain management in patient undergoing laparoscopic ventral hernia repair. |
|
Scientific Title of Study
|
THE EFFICACY OF LAPAROSCOPIC GUIDED TRANSVERSE ABDOMINIS PLANE BLOCK IN LAPAROSCOPIC VENTRAL HERNIA REPAIR - A RANDOMISED CONTROL 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 |
DR C REVATHI |
| Designation |
DNB RESIDENT |
| Affiliation |
Dr Rangarajan Memorial Hospital ( Sundaram medical foundation ) |
| Address |
Department of general surgery
Shanthi colony, 4th avenue anna nagar chennai 600040
Chennai
TAMIL NADU
600040
India |
| Phone |
9445482436 |
| Fax |
|
| Email |
revuchand@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR V RAJAKUMAR |
| Designation |
CONSULTANT |
| Affiliation |
Dr Rangarajan Memorial Hospital ( Sundaram medical foundation ) |
| Address |
Department of general surgery
Shanthi colony, 4th avenue anna nagar chennai 600040
Chennai
TAMIL NADU
600040
India |
| Phone |
9840182920 |
| Fax |
|
| Email |
vrajakumar20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR V RAJAKUMAR |
| Designation |
CONSULTANT |
| Affiliation |
Dr Rangarajan Memorial Hospital ( Sundaram medical foundation ) |
| Address |
Department of general surgery
Shanthi colony, 4th avenue anna nagar chennai 600040
Chennai
TAMIL NADU
600040
India |
| Phone |
9840182920 |
| Fax |
|
| Email |
vrajakumar20@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Ranagarajan Memorial hospital
(Sundaram medical foundation)
5th floor no 1-4
Department of general surgery
4th avenue , shanthi colony, anna nagar, chennai - 600040
|
|
|
Primary Sponsor
|
| Name |
DR C REVATHI |
| Address |
B3, Rajus sapphire, chandra prabhu colony, ponniamman medu, madhavaram, chennai - 600110 |
| Type of Sponsor |
Other [self (This is post graduate thesis study )] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Rangarajan Memorial Hospital Sundaram medicazl foundation |
Shnathi colony , 4th avenue anna nagar chennai tamilnadu 6000040 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR C REVATHI |
Sundaram medical foundation ( Dr Ranagarajan memorial hospital ) |
fifth floor
no 1-4
Department of general surgery
shanthi colony, 4th avenue, anna nagar chennai 6000040
Chennai
TAMIL NADU |
9445482436
revuchand@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sundarammedicalfoundation(DrRangarajanMemorialHospital) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K43||Ventral hernia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
laparoscopic guided transversus abdominis plane block in patients undergoing laparoscopic ventral hernia repair |
To compare the need of analgesics and reduction of pain post operatively between two groups TAP Block and non-TAP block.
|
| Comparator Agent |
patient getting analgesics who is undergoing laparoscopic ventral hernia repair |
to compare the need of analgesic requirements on the day of surgery and
to determine the pain after surgery without transverse abdominis plane block
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age above 18 yrs.
Who provide consent for the study.
All elective as well as emergency cases
All patients undergoing laparoscopic ventral hernia repair.
|
|
| ExclusionCriteria |
| Details |
Pregnancy.
All patients undergoing open ventral hernia repair.
Patients requiring epidural analgesia.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the need of analgesics on the day of operation between two groups TAP Block and non-TAP block |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine effectiveness of TAP block in reduction of pain after surgery using VAS (visual analog scale) in intervention group.
To determine the safety of laparoscopic guided TAP block in ventral hernia repair.
|
1 year |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
30/04/2024 |
| 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="1"
Months="0"
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
|
This is a two arm randomized control trial to compare the efficacy of laparoscopic guided transverse abdominis plane block in laparoscopic ventral hernia repair . The primary outcome To compare the need of analgesics on the day
of operation between two groups TAP Block and non-TAP block. Secondary outcome is o determine effectiveness of TAP block
in reduction of pain after
surgery using VAS (visual analog scale) in
intervention group and to determine the safety of laparoscopic guided TAP block in ventral hernia repair . |