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Completed

NCT Number: NCT06608056

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

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pakistan Air Force Hospital

Islamabad, Capital Territory, 44000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pain management after surgery

Drug

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.

Primary outcomes

  1. 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

  1. Flatus

    Time frame: within 24 hours following surgery

    Time to passing flatus

  2. nausea/vomiting

    Time frame: within 24 hours following surgery

    time when nausea/vomiting was not present in the patient

  3. Time to ambulation

    Time frame: within 24 hours following surgery

    time after surgery when the patient started ambulating

  4. rescue analgesia

    Time frame: within 24 hours following surgery

    number of times rescue analgesia was used

  5. Mean arterial pressure

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

    systolic and diastolic blood pressures were measured for the patients at intervals, and then mean arterial pressures were calculated

  6. Heart rate

    Time frame: 2-, 6-, 12-, 24 hours

    Heart rate was measured at intervals in beats per minute

  7. oxygen saturation

    Time frame: 2-, 6-, 12-, 24 hours

    oxygen saturation was noted at intervals

Sponsors and collaborators

Lead sponsor

Pakistan Air Force (PAF) Hospital Islamabad

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 23, 2024
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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