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Clinical Trials/NCT06608056
NCT06608056
Completed
Not Applicable

Comparing Opioid Vs Non Opioid Analgesics for Postoperative Pain Management in Unilateral Primary Open Inguinal Hernia Repair

Pakistan Air Force (PAF) Hospital Islamabad1 site in 1 country60 target enrollmentJanuary 1, 2024

Overview

Phase
Not Applicable
Intervention
Pain management after surgery
Conditions
Inguinal Hernia Unilateral
Sponsor
Pakistan Air Force (PAF) Hospital Islamabad
Enrollment
60
Locations
1
Primary Endpoint
Visual analogue scale - pain score
Status
Completed
Last Updated
last year

Overview

Brief Summary

To control post-operative pain, multiple drugs are available, and in the western countries opioids are preferred. However, they have their own side effects, and so to reduce their dependence, multiple adjuncts are used. We compared the use of opioids vs just non steroidal anti-inflammatory drugs on post-operative pain control following inguinal hernia surgery

Detailed Description

Inguinal hernia repair is one of the most common surgeries performed by general surgeons worldwide. The preferred procedure for primary open inguinal hernias is open mesh repair (tension-free)-also called Lichtenstein repair. Opioids remain the mainstay for post-operative analgesia, however, they have a tendency for dependence along with other side effects. Non-steroidal anti-inflammatory drugs (NSIADs) have been used as adjuncts to decrease the use of opioids, however, usually NSAIDs are not used in isolation following surgery. We compared post-operative analgesia following primary open inguinal hernia repair, with patients receiving only opioids vs patients only receiving NSAIDs. 60 patients were randomized in to 2 groups. Group A patients received tramadol injection (opioid) every 8 hours, while patients in Group B received injection ketorolac (NSAID) every 8 hourly. Pain was measured using visual analogue score at 2-, 6-, 12- and 24-hours following surgery.

Registry
clinicaltrials.gov
Start Date
January 1, 2024
End Date
June 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Pakistan Air Force (PAF) Hospital Islamabad
Responsible Party
Principal Investigator
Principal Investigator

Syed Moiz Ahmed

Post-graduate resident, Principle Investigator, Department of General Surgery

Pakistan Air Force (PAF) Hospital Islamabad

Eligibility Criteria

Inclusion Criteria

  • Undergoing elective primary unilateral open inguinal hernia repair under spinal anesthesia - Lichtenstein repair with prolene mesh
  • ASA I or II
  • Ages 18 - 65

Exclusion Criteria

  • Patient on chronic pain meds
  • Patient receiving analgesics 24hrs prior to surgery
  • Incarcerated or strangulated hernia or recurrent hernia
  • BMI \>40
  • Allergic to medications being tested in this study

Arms & Interventions

Tramadol

Patients received injection tramadol 50 mg intravenously every 8 hourly following surgery

Intervention: Pain management after surgery

Ketorolac

Patients received injection tramadol 30 mg intravenously every 8 hourly following surgery

Intervention: Pain management after surgery

Outcomes

Primary Outcomes

Visual analogue scale - pain score

Time Frame: 2-, 6-, 12-, 24-hours following surgery

Visual analogue score to quantify pain following laparoscopic cholecystectomy. Maximum value is 10 (which means worst pain), and minimum value is 0 (which means no pain).

Secondary Outcomes

  • Flatus(within 24 hours following surgery)
  • nausea/vomiting(within 24 hours following surgery)
  • Time to ambulation(within 24 hours following surgery)
  • rescue analgesia(within 24 hours following surgery)
  • Mean arterial pressure(2-, 6-, 12-, 24-hours following surgery)
  • Heart rate(2-, 6-, 12-, 24 hours)
  • oxygen saturation(2-, 6-, 12-, 24 hours)

Study Sites (1)

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