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Comparing Opioids Vs NSAIDs for Postoperative Pain Management in Unilateral Primary Open Inguinal Hernia Repair

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06608056
Enrollment
60
Registered
2024-09-23
Start date
2024-01-01
Completion date
2024-06-30
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia Unilateral, Pain Management

Keywords

Lichtenstein repair, ketorolac, tramadol, opioid, visual analogue score, non-steroidal anti-inflammatory drugs

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.

Interventions

Patients in Group A received injection tramadol 50mg intravenously every 8 hours following surgery. Patients in Group B received injection ketorolac 30mg intravenously every 8 hours following surgery.

Sponsors

Pakistan Air Force (PAF) Hospital Islamabad
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Visual analogue scale - pain score2-, 6-, 12-, 24-hours following surgeryVisual 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

MeasureTime frameDescription
nausea/vomitingwithin 24 hours following surgerytime when nausea/vomiting was not present in the patient
Time to ambulationwithin 24 hours following surgerytime after surgery when the patient started ambulating
rescue analgesiawithin 24 hours following surgerynumber of times rescue analgesia was used
Flatuswithin 24 hours following surgeryTime to passing flatus
Heart rate2-, 6-, 12-, 24 hoursHeart rate was measured at intervals in beats per minute
oxygen saturation2-, 6-, 12-, 24 hoursoxygen saturation was noted at intervals
Mean arterial pressure2-, 6-, 12-, 24-hours following surgerysystolic and diastolic blood pressures were measured for the patients at intervals, and then mean arterial pressures were calculated

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026