| CTRI Number |
CTRI/2025/08/092813 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
11/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparing Ultrasound-guided Ilioinguinal/Iliohypogastric Nerve Block Alone And With Subcostal Nerve Block For Better Pain Relief in Patients Undergoing Hernia Surgery |
|
Scientific Title of Study
|
Efficacy Of Ultrasound-guided Ilioinguinal/Iliohypogastric Nerve Block With And Without Subcostal Nerve Block For Post-operative Analgesia In Patients Undergoing Hernia Repair Surgery- A Double Blinded 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 Prasanna Vadhanan |
| Designation |
HOD |
| Affiliation |
Vinayaka Missions Medical College and Hospital, Karaikal |
| Address |
Room no 1, Department of Anaesthesiology, Vinayaka mission medical college and hospital ,Keezhakasakudy Medu, Kottucherry Post
Karaikal
PONDICHERRY
609609
India
Karaikal
PONDICHERRY
609609
India |
| Phone |
9486489690 |
| Fax |
|
| Email |
vadhanan.prasanna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ampalaya Meenu Raghunathan |
| Designation |
Junior Resident/Post Graduate |
| Affiliation |
Vinayaka Missions Medical College and Hospital, Karaikal |
| Address |
Room no 2, Department of Anaesthesiology, Vinayaka mission medical college and hospital, Keezhakasakudy Medu, Kottucherry Post
Karaikal
PONDICHERRY
609609
India
Karaikal
PONDICHERRY
609609
India |
| Phone |
8779609070 |
| Fax |
|
| Email |
meenuampalaya.21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ampalaya Meenu Raghunathan |
| Designation |
Junior Resident/Post Graduate |
| Affiliation |
Vinayaka Missions Medical College and Hospital, Karaikal |
| Address |
Room no 2, Department of Anaesthesiology, Vinayaka mission medical college and hospital, Keezhakasakudy Medu, Kottucherry Post
Karaikal
PONDICHERRY
609609
India
Karaikal
PONDICHERRY
609609
India |
| Phone |
8779609070 |
| Fax |
|
| Email |
meenuampalaya.21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Medical College and Hospital, Karaikal |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Medical College and Hospital |
| Address |
Keezhakasakudy Medu, Kottucherry , Karaikal, Puducherry 609609 |
| 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 |
| Dr Ampalaya Meenu Raghunathan |
Vinayaka Missions Medical College and Hospital |
Department of Anaesthesiology, Vinayaka Missions Medical College and Hospital, Keezhakasakudymedu,Kottuchery post, Karaikal, Puducherry-609609
Karaikal
PONDICHERRY |
8779609070
meenuampalaya.21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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 |
Group A |
Patients will undergo preoperative ultrasound screening and under ultrasound guidance will receive Ilioinguinal and Iliohypogastric nerve block using 5ml of 0.5 percentage Bupivacaine and 5ml of 0.5 percentage Bupivacaine for subcostal nerve block before undergoing spinal anaesthesia for the surgery |
| Comparator Agent |
Group B |
Patients will undergo preoperative ultrasound screening and under ultrasound guidance will receive Ilioinguinal and Iliohypogastric nerve block using 5ml of 0.5 percentage Bupivacaine and 5ml of normal saline for subcostal nerve block before undergoing spinal anaesthesia for the surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
1) ASA physical status 1 and 2 patients posted for unilateral open inguinal hernia surgery
2) Body Mass Index (BMI) less than 30 kg per metre square
|
|
| ExclusionCriteria |
| Details |
1) Known allergies to local anesthetics and analgesics
2) Coagulation disorders
3) Body Mass Index (BMI) more than 30 kg per metre square
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
-To compare the rescue analgesic requirement in the first 24 hours of post-operative period with and without Subcostal nerve block
|
0, 4 hours, 6 hours, 12 hours, 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| -To compare the time until first analgesic requirement using Visual Analogue Scale(VAS) scores |
0, 4 hours, 6 hours, 12 hours, 24 hours |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
26/08/2025 |
| 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
|
Summary: This study investigates whether adding a subcostal nerve block to the commonly used ilioinguinal/iliohypogastric (II/IH) nerve block provides better post-operative pain relief for patients undergoing open inguinal hernia repair. The research is conducted as a single-blinded randomized controlled trial at a tertiary care hospital involving 68 male patients (aged 18–65, ASA I–II, BMI less than 30). Participants are randomly divided into: Aims & Objectives: -
Primary Objective: Compare the need and timing of rescue pain medication within 24 hours post-surgery. -
Secondary Objectives: Compare intra-operative pain control, length of hospital stay, and post-operative nausea/vomiting. Methodology: -
All nerve blocks are performed under ultrasound guidance. -
Pain is assessed using the Visual Analogue Scale at 0, 4, and 24 hours post-op. -
Data is analyzed statistically with significance set at p less than 0.05. Significance: -
This is the first RCT exploring whether adding a subcostal block improves analgesia in this context. -
Aims to improve post-surgical comfort, reduce opioid use, shorten hospital stay, and contribute to enhanced recovery protocols. Ethical Considerations: |