| CTRI Number |
CTRI/2025/07/091326 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study of postoperative pain relief between transversus abdominis plane block and transversalis fascia plane block by ultrasound guided technique in unilateral inguinal hernia repair |
|
Scientific Title of Study
|
Randomized controlled study comparing ultrasound-guided transversus abdominis plane block and transversalis fascia plane block for postoperative analgesia in unilateral inguinal hernia repair at a tertiary care hospital |
| 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 ANITHA T |
| Designation |
Postgraduate Resident |
| Affiliation |
Kodagu institute of medical sciences Madikeri |
| Address |
Department of Anaesthesiology
Kodagu institute of medical sciences Madikeri Karnataka
Kodagu
KARNATAKA
571201
India |
| Phone |
7339660571 |
| Fax |
|
| Email |
anitha.thangavelu1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr NISHEED JOSEPH |
| Designation |
Associate professor |
| Affiliation |
Kodagu institute of medical sciences Madikeri |
| Address |
Department of Anaesthesiology
Kodagu institute of medical sciences Madikeri Karnataka
Kodagu
KARNATAKA
571201
India |
| Phone |
9545566263 |
| Fax |
|
| Email |
dr.nisheed.joseph@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr NISHEED JOSEPH |
| Designation |
Associate professor |
| Affiliation |
Kodagu institute of medical sciences Madikeri |
| Address |
Department of Anaesthesiology
Kodagu institute of medical sciences Madikeri Karnataka
Kodagu
KARNATAKA
571201
India |
| Phone |
9545566263 |
| Fax |
|
| Email |
dr.nisheed.joseph@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kodagu institute of medical sciences madikeri Karnataka India pincode 571201 |
|
|
Primary Sponsor
|
| Name |
Dr ANITHA T |
| Address |
Department of Anesthesiology
Kodagu institute of medical sciences madikeri karnataka India pincode 571201 |
| 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 |
| Dr NISHEED JOSEPH |
Kodagu institute of medical sciences Madikeri |
Room no 202 Major Operation Theatre
Department of Anaesthesiology
Kodagu institute of medical sciences madikeri Karnataka
Kodagu
KARNATAKA |
9545566263
dr.nisheed.joseph@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kodagu institute of medical sciences madikeri |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Transversalis fascia plane block |
Under ultrasound guidance with curvilinear ultrasound probe of 2 to 5 MHz with 100 mm 21 gauge peripheral nerve stimulator needle Block given using 25 ml of 0.25% bupivacaine and monitored for postoperative pain relief till visual analogue score more than 3 |
| Intervention |
Transversus Abdominis Plane block |
Under ultrasound guidance with curvilinear ultrasound probe of 2 to 5 MHz with 100 mm 21 gauge peripheral nerve stimulator needle Block given using 25 ml of 0.25% bupivacaine and monitored for postoperative pain relief till visual analogue score more than 3 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing unilateral open inguinal hernia mesh repair as elective procedure.
2. Patients aged between 18 and 65 years
3. Patient willing to give informed consent
4. American society of Anaesthesiologists Physical status (ASA PS) grade I & II
5. Body Mass Index (BMI) between 18 and 35 kg/m2. |
|
| ExclusionCriteria |
| Details |
1. Known allergies to local anaesthetics
2. Redness or infection at the site of injection
3. Coagulation disorders
4. Obstructed and strangulated hernia
5. Renal or liver disease. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the duration of analgesia between Transversus Abdominis Plane block and Transversalis
Fascia Plane block in unilateral inguinal hernia surgical repair. |
Time interval from administration of block to the point when visual analogue score more than 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the pain severity between Transversus Abdominis Plane block and Transversalis Fascia plane block in unilateral inguinal hernia surgical repair.
|
Visual analogue score of 0 for no pain and score 10 for worst pain measured every 2nd hourly till 24 hours and every 6th hourly till 48 hours |
To compare patient satisfaction between Transversus Abdominis Plane block and Transversalis
Fascia Plane block in unilateral inguinal hernia surgical repair. |
Likert scale of 1 for very dissatisfied and score 5 for very satisfied measured every 2nd hourly till 24 hours and every 6th hourly till 48 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
02/08/2025 |
| 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="6"
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
|
Comparative study of postoperative pain relief between transversus abdominis plane block and transversalis fascia plane block by ultrasound guided technique in unilateral inguinal hernia repair by using visual analogue score and patient satisfaction using likert scale in 60 patients in a tertiary care hospital |