| CTRI Number |
CTRI/2025/03/082847 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
13/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of post operative pain relief between intravenous diclofenac with acetaminophen in combination and intravenous diclofenac alone in patients undergoing inguinal hernia surgery |
|
Scientific Title of Study
|
An evaluation of opioid sparing effects of intravenous diclofenac - acetaminophen combination when compared to diclofenac alone in patients undergoing inguinal hernia repair - A double blinded randomised trial |
| 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 Indira Kumari |
| Designation |
Professor |
| Affiliation |
RNT Medical College |
| Address |
Department of Anaesthesiology,
RNT medical college, Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414176760 |
| Fax |
|
| Email |
dr_ikumari@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indira Kumari |
| Designation |
Professor |
| Affiliation |
RNT Medical College |
| Address |
Department of Anaesthesiology,
RNT medical college, Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414176760 |
| Fax |
|
| Email |
dr_ikumari@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Narla Lakshmi Bhavani Chowdary |
| Designation |
Post Graduate Resident |
| Affiliation |
RNT Medical College |
| Address |
Department of Anaesthesiology,
RNT medical college, Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9603655681 |
| Fax |
|
| Email |
bhavanichowdary161@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, R.N.T Medical College, Udaipur 313001, Rajasthan, India |
|
|
Primary Sponsor
|
| Name |
Rabindranath Tagore medical college |
| Address |
Department of Anaesthesiology RNT Medical College, Udaipur Rajasthan 313001 |
| 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 |
| Dr Narla Lakshmi Bhavani Chowdary |
Maharana Bhupal Government Hospital |
2nd floor Main Building, Main OT Complex, RNT Medical college
Udaipur
RAJASTHAN |
9603655681
bhavanichowdary161@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RNT Medical College and Controller and Attached Hospitals Udaipur |
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 |
| Intervention |
Intravenous Diclofenac |
At the end of surgery intravenous 75mg DICLOFENAC diluted in 10ml isotonic saline over 10min along with intravenous 100ml isotonic saline over 15min. Postoperatively in 24 hours intravenous 75mg diclofenac every 12 hours and 100ml isotonic saline intravenous every 6 hours |
| Comparator Agent |
Intravenous Diclofenac and Intravenous Acetaminophen |
At the end of surgery Intravenous 75mg Diclofenac diluted in 10ml isotonic saline over 10 min and 100ml of intravenous 1gm Acetaminophen over 15 mins. Postoperatively in 24 hours intravenous 75mg diclofenac every 12 hours and 100ml of 1gm acetaminophen intravenous every 6 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
ASA Grade 1 & 2
Undergoing elective inguinal hernia surgeries under subarachnoid block |
|
| ExclusionCriteria |
| Details |
Patients who are not willing to participate in study
ASA grade 3& 4
History of drug or alcohol abuse
History of coagulation abnormalities
Known hypersensitivity to any of study medication
Patient on long term analgesia
Patient with contraindication to spinal anesthesia
Failure of spinal anesthesia
|
|
|
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 assess the total post operative rescue analgesic(Tramadol) consumption |
In 24 hours post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess time to first request for rescue analgesia
2.To assess the post operative pain at rest and movement
3.To assess episodes of nausea, retching and vomiting
4. Overall patient satisfaction |
in 24 hours post operatively |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
24/03/2025 |
| 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)
|
Closed to Recruitment of Participants |
| 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
|
The aim of the study will be to compare the opioid sparing effects of intravenous diclofenac - acetaminophen with diclofenac alone in providing post operative analgesia following inguinal hernia repair surgery under subarachnoid block |