| CTRI Number |
CTRI/2024/03/063563 [Registered on: 04/03/2024] Trial Registered Prospectively |
| Last Modified On: |
29/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparison of external oblique and subcostal TAP block |
|
Scientific Title of Study
|
A Comparative Study Of External Oblique
Intercostal Plane Block Versus Subcostal
Transverse Abdominis Block for Upper
Abdominal Laproscopic Surgeries. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divya Kheskani |
| Designation |
Associate Professor |
| Affiliation |
GCS Medical College, Hospital and Research Centre |
| Address |
GCS medical College, Hospital and Research Centre
Deaprtment of anaesthesia, GCS medical College, Hospital and Research Centre, opp. DRM office, Nr. Chamunda bridge, Naroda Road, Ahmedabad
Ahmadabad
Ahmadabad
GUJARAT
391760
India |
| Phone |
8980738209 |
| Fax |
|
| Email |
divya.kheskani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Divya Kheskani |
| Designation |
Associate Professor |
| Affiliation |
GCS Medical College, Hospital and Research Centre |
| Address |
GCS medical College, Hospital and Research Centre
Deaprtment of anaesthesia, GCS medical College, Hospital and Research Centre, opp. DRM office, Nr. Chamunda bridge, Naroda Road, Ahmedabad
Ahmadabad
GUJARAT
391760
India |
| Phone |
8980738209 |
| Fax |
|
| Email |
divya.kheskani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Divya Kheskani |
| Designation |
Associate Professor |
| Affiliation |
GCS Medical College, Hospital and Research Centre |
| Address |
GCS medical College, Hospital and Research Centre
Deaprtment of anaesthesia, GCS medical College, Hospital and Research Centre, opp. DRM office, Nr. Chamunda bridge, Naroda Road, Ahmedabad
Ahmadabad
GUJARAT
391760
India |
| Phone |
8980738209 |
| Fax |
|
| Email |
divya.kheskani@gmail.com |
|
|
Source of Monetary or Material Support
|
|
GCS medical College, Hospital and Research Centre |
|
|
Primary Sponsor
|
| Name |
GCS MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
GCS Medical College, Hospital and Research Centre, opp. DRM office, Nr. Chamunda bridge, Naroda Road, Ahmedabad |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Divya Kheskani |
GCS medical College, Hospital and Research Centre, |
Department Of Anaesthesia, GCS Medical College, Hospital & Research Centre, Naroda Road,near chamunda bridge
Ahmadabad
GUJARAT |
8980738209
divya.kheskani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, GCS medical college, |
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 |
External oblique intercostal plane (EOIP) |
ultrasonography guided administeration of Local anaesthetic superior or
deep of the external oblique muscle from the
sixth intercostal space leading to the blockage of
thoracoabdominal nerves at T6-T10. |
| Comparator Agent |
subcostal transverse abdominis plane |
ultrasonography guided deposition of local anesthetic
in the transverse abdominis plane inferior and
parallel to the costal margin. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologists (ASA)
physical status grade I -II,
30 to 60 yrs of either Gender
Scheduled to undergo elective surgeries under
GA. |
|
| ExclusionCriteria |
| Details |
Allergy to local anesthetics,
Refusal to consent
Infection at the site of injection,
Coagulopathy, |
|
|
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 |
Time of First postoperative analgesics request
(rescue analgesia)
Total duration of analgesia
Postoperative pain score |
1,2,4,6,8,12,24 HOURS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative nausea & vomitting |
1,2,4,6,8,12,24 HOURS |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
12/03/2024 |
| 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
|
The External oblique intercostal plane (EOIP) block is a novel technique reported by Hamilton et al. performed by administering LA superior or deep of the external oblique muscle from the sixth intercostal space leading to the blockage of thoracoabdominal nerves at T6-T10.
The subcostal transverse abdominis plane (SCTAP) block is the deposition of local anesthetic in the transverse abdominis plane inferior and parallel to the costal margin.
AIMS AND OBJECTIVES
To evaluate efficacy of USG guided external oblique block versus Subcostal Transverse abdominus plane block Patients Included in study will be randomly divided in two equal groups of 50 each
Group A : ultrasonography guided external oblique block
Group B : ultrasonography guided subcostal transverse abdominis plane block
Block to be administered postoperatively , immediately on completion of surgery prior to extubation.
0.2% Ropivacaine with 100 µg to be used as drug solution 20 ml on either side in both groups. |