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

September 19, 2024 updated by: Syed Moiz Ahmed, Pakistan Air Force (PAF) Hospital Islamabad

Comparing Opioid Vs Non Opioid Analgesics 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Capital territory
      • Islamabad, Capital territory, Pakistan, 44000
        • Pakistan Air Force Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tramadol
Patients received injection tramadol 50 mg intravenously every 8 hourly following surgery
Drug: Pain management after surgery
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.
Experimental: Ketorolac
Patients received injection tramadol 30 mg intravenously every 8 hourly following surgery
Drug: Pain management after surgery
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
2-, 6-, 12-, 24-hours following surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Flatus
Time Frame: within 24 hours following surgery
Time to passing flatus
within 24 hours following surgery
nausea/vomiting
Time Frame: within 24 hours following surgery
time when nausea/vomiting was not present in the patient
within 24 hours following surgery
Time to ambulation
Time Frame: within 24 hours following surgery
time after surgery when the patient started ambulating
within 24 hours following surgery
rescue analgesia
Time Frame: within 24 hours following surgery
number of times rescue analgesia was used
within 24 hours following surgery
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
2-, 6-, 12-, 24-hours following surgery
Heart rate
Time Frame: 2-, 6-, 12-, 24 hours
Heart rate was measured at intervals in beats per minute
2-, 6-, 12-, 24 hours
oxygen saturation
Time Frame: 2-, 6-, 12-, 24 hours
oxygen saturation was noted at intervals
2-, 6-, 12-, 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pakistan Air Force (PAF) Hospital Islamabad

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

June 28, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

September 19, 2024

First Submitted That Met QC Criteria

September 19, 2024

First Posted (Actual)

September 23, 2024

Study Record Updates

Last Update Posted (Actual)

September 23, 2024

Last Update Submitted That Met QC Criteria

September 19, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGR-2021-137-2499-2 (Other Identifier: PAF Hospital ethical committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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