| CTRI Number |
CTRI/2025/04/083868 [Registered on: 02/04/2025] Trial Registered Prospectively |
| Last Modified On: |
01/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Pain Relief Strategies for Open Inguinal Hernioplasty Ultrasound-Guided Ilioinguinal Nerve Block vs. Lignocaine 5 percent Patch |
|
Scientific Title of Study
|
EFFECT OF ULTRASOUND GUIDED ILIOINGUINAL NERVE BLOCK AND LIGNOCAINE 5 percent PATCH ON POSTOPERATIVE PAIN IN PATIENTS UNDERGOING OPEN INGUINAL HERNIOPLASTY: A RANDOMIZED COMPARATIVE 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. Shreyanshi Teotia |
| Designation |
Junior Resident |
| Affiliation |
King Georges Medical University |
| Address |
King George Medical University, (Erstwhile Chhatrapati Shahuji Maharaj Medical University), Chowk, Lucknow, Uttar Pradesh.
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8218063326 |
| Fax |
|
| Email |
drshreyanshiteotia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Sateesh Verma |
| Designation |
|
| Affiliation |
King George Medical University |
| Address |
King George Medical University, (Erstwhile Chhatrapati Shahuji Maharaj Medical University), Chowk, Lucknow, Uttar Pradesh.
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7379837390 |
| Fax |
|
| Email |
Sateeshverma24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SHREYANSHI TEOTIA |
| Designation |
Junior Resident |
| Affiliation |
King Georges Medical University |
| Address |
King George Medical University, (Erstwhile Chhatrapati Shahuji Maharaj Medical University), Chowk, Lucknow, Uttar Pradesh.
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8218063326 |
| Fax |
|
| Email |
drshreyanshiteotia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shah Mina Rd, Chowk, Lucknow, Uttar Pradesh 226003
King Georges Medical University Shah Mina Rd, Chowk, Lucknow, Uttar Pradesh 226003 |
|
|
Primary Sponsor
|
| Name |
King George Medical University Department of Anesthesiology |
| Address |
King George Medical University Department of Anesthesiology pincode 226003 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| nil |
nil |
| nil |
nil |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DRSHREYANSHI TEOTIA |
Department of Anaesthesiology |
King George Medical University,room number 10 Chowk, Lucknow, Uttar Pradesh.
Lucknow
UTTAR PRADESH |
08218063326
drshreyanshiteotia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| King George Medical University |
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 |
Lignocaine 5% patch |
The comparator agent in this study is the Lignocaine 5% Patch, a topical, slow-release patch containing 5% lignocaine, a local anesthetic. This patch works by releasing lignocaine slowly over time, providing analgesia to the skin and underlying tissues. It is indicated for relief of postoperative pain in patients undergoing open inguinal hernioplasty, and is applied topically to the skin overlying the inguinal region, providing prolonged analgesia that typically lasts several hours. |
| Intervention |
Ultrasound-guided ilioinguinal nerve block |
Ultrasound-guided ilioinguinal nerve block: This intervention involves using ultrasound guidance to administer a local anesthetic block to the ilioinguinal nerve, which provides sensory innervation to the inguinal region. The goal of this block is to reduce postoperative pain in patients undergoing open inguinal hernioplasty.Lignocaine 5% patch: This intervention involves applying a topical patch containing 5% lignocaine (a local anesthetic) to the skin overlying the inguinal region. The patch is designed to release lignocaine slowly over time, providing analgesia to the area and reducing postoperative pain. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
all patients are scheduled for open hernioplasty surgery ASA I - II - III written form consent will be taken body weight 50-80 kg |
|
| ExclusionCriteria |
| Details |
pregnancy or breastfeeding known allergy to components of the anesthesia drugs history of coagulopathy or bleeding disorders severe neurological or psychiatric disorders pre existing peripheral neuropathy
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| post operative VAS score |
48 hours after surgery
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| patient satisfaction for pain management |
48 hours post surgery |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
14/04/2025 |
| 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 Yet Recruiting |
| 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
|
Inguinal hernioplasty is one of the common elective surgeries performed. It is associated with mild to moderate pain. Ilioinguinal block minimizes pain after tissue injury, avoid spinal sensitization, and diminish the prevalence of chronic pain. The use of ultrasound technique in nerve block will allow real-time visualization of the nerves and drug distribution, so less drug will be needed and less side effects.
The lidocaine (5%) patch offers a double mode of action in the treatment of localized neuropathic pain, delivering a mechanical barrier effect as well as pharmaceutical action through voltage-gated sodium-channel block by lidocaine activity,
By conducting this study we want to compare analgesic effect of ilioinguinal nerve block and lignocaine 5% patch in patient undergoing inguinal hernioplasty. |