| CTRI Number |
CTRI/2025/08/093277 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Two techniques for Pain Relief After Hernia Surgery |
|
Scientific Title of Study
|
A randomized interventional trial. Comparative assessment of pain relief by ultrasound guided tender point blockade vs ilioinguinal nerve block in chronic pain post herniorrhaphy |
| 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 Shikha Soni |
| Designation |
Professor |
| Affiliation |
DR SN MEDICAL COLLEGE |
| Address |
Main OT Complex 1st floor Dept of anaesthesia MGH Hospital DR SN MEDICAL COLLEGE Jodhpur
Jodhpur
RAJASTHAN
342001
India |
| Phone |
9950198704 |
| Fax |
|
| Email |
shikhasoni.19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
NARENDREN K |
| Designation |
PG Student |
| Affiliation |
DR SN MEDICAL COLLEGE |
| Address |
Main Operation Theater First floor Department of anaesthesia MGH Hospital DR SN MEDICAL COLLEGE Jodhpur
Dr SN Medical College, Jodhpur
Jodhpur
RAJASTHAN
342001
India |
| Phone |
9487508663 |
| Fax |
|
| Email |
narendrenkrishnamurthy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NARENDREN K |
| Designation |
PG Student |
| Affiliation |
DR SN MEDICAL COLLEGE |
| Address |
Main Operation Theater First floor Department of anaesthesia MGH Hospital DR SN MEDICAL COLLEGE Jodhpur
Dr SN Medical College, Jodhpur
Jodhpur
RAJASTHAN
342001
India |
| Phone |
9487508663 |
| Fax |
|
| Email |
narendrenkrishnamurthy@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR SN MEDICAL COLLEGE JODHPUR |
|
|
Primary Sponsor
|
| Name |
DR SN MEDICAL COLLEGE |
| Address |
Dr SN Medical College Shastri Nagar Jodhpur |
| 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 |
| NARENDREN K |
MGH Hospital |
Main Operation Theater First floor Department of anaesthesia MGH Hospital DR SN MEDICAL COLLEGE Jodhpur
Jodhpur
RAJASTHAN |
09487508663
narendrenkrishnamurthy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR SN MEDICAL COLLEGE JODHPUR 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 |
| Comparator Agent |
Ilioinguinal nerve block |
The patient will be placed in a supine position and under all aseptic precautions the anterior superior iliac spine and inguinal ligament will be identified with a high frequency linear probe positioned perpendicular to the inguinal ligament to locate the ilioinguinal nerve between the internal oblique and transverse abdominus muscles followed by needle advancement to the fascial plane to target the nerve |
| Intervention |
Tender point blockade |
The inguinal area will be sterilized and a sterile drape will be placed a skin mark will align with the ultrasound probe and Colour Doppler ultrasonography will identify blood vessels to avoid intravascular injection a 22G needle will be guided in plane to inject the solution just above the spermatic cord with spread confirmation on ultrasound |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient who underwent herniorraphy surgery having pain for more than 6 months with intensity of more than 5 by VAS |
|
| ExclusionCriteria |
| Details |
1)Patient who are having recurrent inguinal hernia 2)Allergy to local anaesthetics
3)Infection in wound area
4)Drug abuse |
|
|
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 |
| The primary outcome is post procedure pain assessment by VAS Pain assessment scales |
0 minutes, 10 minutes, 1 week, 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain assessment using other pain scales post blockade |
0 minutes, 10 minutes, 1 week, 1 month |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
05/09/2025 |
| 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="0"
Months="1"
Days="15" |
|
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [narendrenkrishnamurthy@gmail.com].
- For how long will this data be available start date provided 30-11-2025 and end date provided 30-11-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
Herniorrhaphy postoperative pain prevention includes preoperative and intraoperative local anaesthetic infiltration field blocks paravertebral blocks tender point blockade and NSAIDs or COX 2 inhibitors preoperative or intraoperative field blocks mainly targeting the ilio-inguinal nerve with or without wound infiltration are more effective than placebo or no treatment for reducing early postoperative pain and reducing the need for additional analgesics. Tender point blockade with 10 ml 0.25% ropivacaine which involves targeting specific areas of muscle or nerve irritation, can also provide relief by addressing localized pain. It has been found to reduce pain and muscle tenderness previously, particularly in patients with myofascial pain after surgery. The technique can be integrated with other pain management approaches, such as local anaesthetic infiltration and nerve blocks, to enhance overall pain control in the post herniorrhaphy chronic pain of 6 months or more and comparing it with ilioinguinal nerve block with 10 ml 0.25% ropivacaine. |