| CTRI Number |
CTRI/2023/04/051242 [Registered on: 03/04/2023] Trial Registered Prospectively |
| Last Modified On: |
31/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
An observational study to assess the analgesic effects of posterior transversus abdominis plane block and lateral transversus abdominis plane block. |
|
Scientific Title of Study
|
A prospective observational study to assess the analgesic effects of posterior transversus abdominis plane block and lateral transversus abdominis plane block. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
C Reshmita Gandhi |
| Designation |
Post Graduate |
| Affiliation |
Sree Balaji medical college and hospital, Chennai |
| Address |
Sree balaji medical college and hospital,
department of anaesthesiology
no.7, clc works road, chrompet
chennai
Chennai
TAMIL NADU
600044.
India |
| Phone |
9345252242 |
| Fax |
|
| Email |
creshmitagandhi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pranjali Kurhekar |
| Designation |
Associate Professor |
| Affiliation |
Sree Balaji medical college and hospital, Chennai |
| Address |
Sree balaji medical college and hospital,
department of anaesthesiology
no.7, clc works road, chrompet
chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
9486414942 |
| Fax |
|
| Email |
pranjalikurhekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
C Reshmita Gandhi |
| Designation |
Post Graduate |
| Affiliation |
Sree Balaji medical college and hospital, Chennai |
| Address |
Sree balaji medical college and hospital,
department of anaesthesiology
no.7, clc works road, chrompet
chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
9345252242 |
| Fax |
|
| Email |
creshmitagandhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sree balaji medical college and hospital,
department of anaesthesiology
no.7, clc works road, chrompet
chennai-600044. |
|
|
Primary Sponsor
|
| Name |
Sree Balaji medical college and hospital |
| Address |
No. 7, CLC works road, Chromepet, Chennai 600044. |
| 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 |
| Reshmita Gandhi |
Sree Balaji medical college and hospital |
Sree balaji medical college and hospital,
department of anaesthesiology
no.7, clc works road, chrompet
chennai
Chennai
TAMIL NADU |
9345252242
creshmitagandhi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients coming for abdominal surgery under general anaesthesia. |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients receiving posterior tap block. Patients receiving lateral tap block. ASA I & II. elective procedures. |
|
| ExclusionCriteria |
| Details |
History of local anaesthetic agent allergy. ASA III, IV. Skin infection in the anterior abdominal wall. Bleeding diasthesis, peripheral neuropathy, neuromuscular disease and psychiatric disorders. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of posterior TAP BLOCK is better than LATERAL TAP block. |
1 year. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| time of first rescue analgesia |
1 year. |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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
|
N/A |
|
Date of First Enrollment (India)
|
08/04/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
08/04/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [creshmitagandhi@gmail.com].
- For how long will this data be available start date provided 17-01-2025 and end date provided 17-01-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Transversus Abdominis Plane (TAP) Block is a regional anaesthesia technique that provides analgesia to the parietal peritoneum as well as the skin and muscles of the anterior abdominal wall. This technique involves injection of a local anesthetic solution into a plane between the internal oblique muscle and transversus abdominis muscle, targeting anterior rami of thoracolumbar nerves originating from the T6 to L1 spinal roots, which provide sensory function to the anterolateral abdominal wall. Traditionally, TAP block has been performed under ultrasound guidance using one of four different approaches, targeting different areas of the anterior abdominal wall: subcostal TAP block provides analgesia to the anterior cutaneous branches of the thoracolumbar nerves T6–9, oblique subcostal TAP block delivers analgesia to anterior cutaneous branches T6-L1, posterior TAP block targets anterior cutaneous branches T9–12, and the lateral/mid-axillary technique blocks the anterior cutaneous branches T10–12. The analgesic effects obtained with TAP block extend from the anterior abdominal wall and parietal peritoneum to the lateral cutaneous branches of T9-L1. In this study, we will be comparing the effectiveness of posterior and lateral approaches. |