| CTRI Number |
CTRI/2025/07/089982 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
01/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Lower Limb surgeries by blocking nerves using sonogpghic techniques for pain relief
|
|
Scientific Title of Study
|
USG guided Ilioinguinal and Iliohypogastric nerve block for post operative analgesia in unilateral inguinal hernia surgeries under spinal anaesthesia. A Randomised control trial 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 |
Moon Prajwal Annaji |
| Designation |
Junior Resident |
| Affiliation |
vIlasrao deshmukh government medical college Latur |
| Address |
Department of Anaesthesiology,
First floor,Surgical Building.
room no 222
Latur
VDGMC Latur PG Hostel
Room no 222
Latur
MAHARASHTRA
413512
India |
| Phone |
8668494386 |
| Fax |
|
| Email |
pmoon41@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Chauhan Shailendra Dattusing |
| Designation |
Professor and head of the department |
| Affiliation |
VDGMC Latur |
| Address |
Department of Anaesthesiology First floor,Surgical Building
Room no 222
Latur
Latur
MAHARASHTRA
413512
India |
| Phone |
7588693032 |
| Fax |
|
| Email |
shailendradc@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chauhan Shailendra Dattusing |
| Designation |
Professor and head of the department |
| Affiliation |
VDGMC Latur |
| Address |
Department of Anaesthesiology
First floor, Surgical Building
Room no 222
Latur
Latur
MAHARASHTRA
413512
India |
| Phone |
7588693032 |
| Fax |
|
| Email |
shailendradc@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Villasrao deshmukh government medical college civil hospital Latur Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Villasrao Deshmukh Government medical college Latur |
| Address |
Latur Maharashtra India
413512 |
| Type of Sponsor |
Government 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 |
| Moon Prajwal Annaji |
Villasrao Deshmukh Government medical college Latur |
Department of Anaesthesiology First floor, Surgical Building Room no 222, Latur
Latur
MAHARASHTRA |
8668494386
pmoon41@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee VDGMC Latur |
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 |
Not applicable |
Not applicable |
| Intervention |
Ultrasound guided Ilioinguinal and iliohypogastric Nerve block |
Patients in the intervention group received a unilateral ultrasound-guided ilioinguinal and iliohypogastric nerve block at the end of surgery. Using a high-frequency linear ultrasound probe (6–13 MHz), the nerves were located in the fascial plane between the internal oblique and transversus abdominis muscles near the anterior superior iliac spine (ASIS). A 22G block needle was inserted in-plane, and 10–20 ml of 0.5% ropivacaine was injected after confirming correct placement via hydrodissection. The procedure was performed under strict aseptic precautions. Control group patients did not receive the nerve block and were managed with standard postoperative analgesia.
|
| Intervention |
Usg guided Ilioinguinal and iliohypogastric Nerve block |
Usg guided Ilioinguinal and iliohypogastric block will be given with 10ml 0.5 percent ropivacaine and patient will be monitored for 24 hours for need of rescue analgesia. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients between age of 20 to 60 years of ASA physical status 1 and 2 undergoing elective non relapsing unilateral inguinal hernia repair |
|
| ExclusionCriteria |
| Details |
Patients with known allergy to local anaesthetics patient with chronic pain not related to inguinal hernia patient with contraindication to spinal anaesthesia and patients with obstructed or strangulated hernia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post operative pain score assessed using visual analogue scale |
Post operative pain score assessed using visual analogue scale VAS at 1 2 3 4 6 12 24 hours after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total rescue analgesia requirement |
Total analgesic requirements in 24 hour since block |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
22/07/2025 |
| 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="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
|
This prospective, randomized interventional study aims to evaluate the efficacy of ultrasound-guided ilioinguinal and iliohypogastric nerve block in providing postoperative analgesia in patients undergoing unilateral inguinal hernia repair under spinal anaesthesia. Pain intensity will be assessed using the Visual Analogue Scale (VAS) at multiple postoperative intervals, and outcomes will include total analgesic consumption, time to first rescue analgesia, and any block-related complications over 24 hours. The study seeks to determine whether the nerve block improves pain control and reduces analgesic requirements compared to standard care.
|