| CTRI Number |
CTRI/2024/11/076140 [Registered on: 01/11/2024] Trial Registered Prospectively |
| Last Modified On: |
30/05/2025 |
| 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
|
Ultrasound-guided Subcostal Transversus Abdominis Plane Block Versus Bilateral Erector Spinae Block For Laparoscopic Inguinal Hernia Repair -Randomised Controlled Triple binded Trial |
|
Scientific Title of Study
|
Ultrasound-guided Subcostal Transversus Abdominis Plane Block Versus Bilateral Erector Spinae Block For
Laparoscopic Inguinal Hernia Repair -A Comparative Randomized Triple -blinded Clinical Trial |
| 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.Lakshmi M |
| Designation |
Second year Post Graduate resident M.D Anesthesiology |
| Affiliation |
Sri Ramachandra Institute of Higher Education And Research |
| Address |
Room No.A6 Anesthesia Department, Sri Ramachandra Institute Of Higher Education and Research,
No.1 Ramachandra Nagar
Porur,
Chennai 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9840478975 |
| Fax |
|
| Email |
peaceworldalways20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Rajesh Kumar Kodali |
| Designation |
Professor M.D Anesthesiology |
| Affiliation |
Sri Ramachandra Institute of Higher Education And Research |
| Address |
Room No.A6,Anesthesia Department, Sri Ramachandra Institute Of Higher Education and Research,
No.1 Ramachandra Nagar
Porur,
Chennai 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9962398266 |
| Fax |
|
| Email |
vrajesh.kodali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Rajesh Kumar Kodali |
| Designation |
Professor M.D Anesthesiology |
| Affiliation |
Sri Ramachandra Institute of Higher Education And Research |
| Address |
Room No.A6,Anesthesia Department, Sri Ramachandra Institute Of Higher Education and Research,
No.1 Ramachandra Nagar
Porur,
Chennai 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9962398266 |
| Fax |
|
| Email |
vrajesh.kodali@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai - 600116 |
|
|
Primary Sponsor
|
| Name |
DrLakshmi M |
| Address |
Room Number 133,Ladies Hostel block number 5 ,Anesthesia Department, Sri Ramachandra Institute of Higher Education and Research, No.1 Ramachandra Nagar, Porur
Chennai 600116
|
| 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 |
| DrLakshmi M |
Sri Ramachandra Institute of Higher Education and Research |
Department of Anesthesia, Operating Rooms Division,Room Number A6,Porur,Chennai
Thiruvallur
TAMIL NADU |
9840478975
peaceworldalways20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL RESEARCH ETHICS COMMITTEE ,SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH, PORUR,CHENNAI-600116 |
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 |
| Comparator Agent |
20ml of 0.25% Bupivacaine as Bilateral Erector Spinae Block |
Participants in this group undergoing Laparoscopic Inguinal Hernia Repair surgeries get Bilateral Erector Spinae Block |
| Intervention |
20ml of0.25% Bupivacaine on each side in Subcostal Transversus Abdominis Plane Block |
Participants in this group undergoing Laparoscopic Inguinal Hernia Repair surgeries get both sides Subcostal Transversus Abdominis Plane Block once after induction of general anesthesia with 20ml of 0.25% Bupivacaine on each side |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 & 2
Patients with Age 18-65yrs
Patients who are willing |
|
| ExclusionCriteria |
| Details |
ASA 3 & 4
Patients with cardiac, respiratory, kidney or liver diseases and chronic drug users
Patients with BMI more than 35
Patients with hypersensitivity to one of the medications used |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To compare Total analgesic requirement upto 24hr after surgery
2.Degree of pain assessed by VNRS upto 24hrs after surgery
3.Any Intraoperative or postoperative problems upto 24hrs to be managed |
1.To compare Total analgesic requirement upto 24hr after surgery upto 24hrs after surgery
2.Degree of pain assessed by VNRS upto 24hrs after surgery
3.Any Intraoperative or postoperative problems upto 24hrs to be managed |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Fentanyl consumption used Intraoperatively till surgery end time.
2.Time for first analgesic request postoperatively within 24hrs after surgery |
The secondary outcome is the Fentanyl consumption used Intraoperatively & the time it takes for the first analgesic request postoperatively after surgery upto 24hrs |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
Final Enrollment numbers achieved (Total)= "58"
Final Enrollment numbers achieved (India)="58" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/11/2024 |
| Date of Study Completion (India) |
20/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="0" |
|
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)
|
Effective pain control is critical to improve clinical outcomes and allow patients to mobilise faster after surgery.Blocking Bilateral Subcostal Transversus Abdominis Plane inferior and parallel to costal margins plays a crucial role in pain control following lower abdominal surgeries.The Subcostal Transverse Abdominis Plane block is given at T9 level along the subcostal margin.The Erector Spinae block is a paraspinal regional anesthesia given in the fascial plane between Erector Spinae muscle and Transverse process covering three vertebral levels caudally and cranially respectively to cover dorsal and ventral ramii suppressing somatic and ventral pain.Both blocks are given in patients undergoing Laparoscopic Inguinal Hernia Repair surgeries to compare which gives better results. |