CTRI/2025/03/082847Not yet recruitingPhase 4
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
Rabindranath Tagore medical college1 site in 1 country80 target enrollmentStarted: March 24, 2025Last updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- To assess the total post operative rescue analgesic(Tramadol) consumption
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- Male
Inclusion Criteria
- •ASA Grade 1 & 2 Undergoing elective inguinal hernia surgeries under subarachnoid block.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
To assess the total post operative rescue analgesic(Tramadol) consumption
Time Frame: In 24 hours post operatively
Secondary Outcomes
- 1. To assess time to first request for rescue analgesia(2.To assess the post operative pain at rest and movement)
Investigators
Dr Indira Kumari
RNT Medical College
Study Sites (1)
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