Clinical trial NCT06608056: Comparing Opioids Vs NSAIDs for Postoperative Pain Management in Unilateral Primary Open Inguinal Hernia Repair
Official title: Comparing Opioid Vs Non Opioid Analgesics for Postoperative Pain Management in Unilateral Primary Open Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia Unilateral
Pain Management
Keywords: Lichtenstein repair
ketorolac
tramadol
opioid
visual analogue score
non-steroidal anti-inflammatory drugs
Lead sponsor: Pakistan Air Force (PAF) Hospital Islamabad
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 \&gt;40
* Allergic to medications being tested in this study

Primary outcomes:
measure: Visual analogue scale - pain score
timeFrame: 2-, 6-, 12-, 24-hours following surgery
Secondary outcomes:
measure: Flatus
timeFrame: within 24 hours following surgery
measure: nausea/vomiting
timeFrame: within 24 hours following surgery
measure: Time to ambulation
timeFrame: within 24 hours following surgery
measure: rescue analgesia
timeFrame: within 24 hours following surgery
measure: Mean arterial pressure
timeFrame: 2-, 6-, 12-, 24-hours following surgery
measure: Heart rate
timeFrame: 2-, 6-, 12-, 24 hours
measure: oxygen saturation
timeFrame: 2-, 6-, 12-, 24 hours
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Pakistan Air Force Hospital
state: Capital territory
Study officials:
References:
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