Gabapentin and Diclofenac Sodium Comparison for Post-Operative Pain Relief

Comparative Efficacy of Gabapentin and Diclofenac Sodium for Post-Operative Pain Relief in Patients Undergoing Major Abdominal Surgeries

Little is known about comparative efficacy of gabapentin and diclofenac sodium in managing post-operative pain. Therefore, this study was planned to compare the efficacy of gabapentin, and diclofenac sodium for post-operative pain relief in patients undergoing major abdominal surgeries.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Gabapentin 600mg; Drug: Diclofenac Sodium 100 MG

Detailed Description

Non-steroidal anti-inflammatory drugs, opioid analgesics, and local and regional anesthesia have been used as preventive interventions, but their role in postoperative pain management remains inconclusive. Gabapentin is a relatively new drug for postoperative pain management whose side effects are well tolerated. If the findings of this study produce similar observations, it would add to the already scarce data and help patients undergoing major abdominal surgeries in the local settings in relieving postoperative pain effectively.

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Bahawalpur, Punjab Province, Pakistan, 63100
      • Bahawal Victoria Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Any gender
• Aged 18-60 years
• Undergoing elective major abdominal surgery under general anesthesia
• With physical status I or II
• Who were able to comprehend and use the Visual Analogue Scale (VAS) for pain assessment

Exclusion Criteria:

• With a known allergy or contraindication to gabapentin, or diclofenac sodium
• A history of peptic ulcer disease
• A history of gastrointestinal bleeding
• Hepatic or renal dysfunction
• Pregnancy or lactation
• With neurological or psychiatric disorders affecting pain perception
• Received opioids, anticonvulsants, antidepressants, or nonsteroidal anti-inflammatory drugs (NSAIDs) within 24 hours before surgery
• With uncontrolled hypertension, ischemic heart disease, or diabetes mellitus
• Those who experienced intraoperative complications necessitating a change in anesthetic plan or postoperative mechanical ventilation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gabapentin group; Patients received a single oral dose of gabapentin 600 mg one hour before surgery.	Drug: Gabapentin 600mg; Patients received a single oral dose of gabapentin 600 mg one hour before surgery.
Experimental: Diclofenac group; Patients were given a single oral dose of diclofenac sodium 100 mg one hour before surgery.	Drug: Diclofenac Sodium 100 MG; Patients were given a single oral dose of diclofenac sodium 100 mg one hour before surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain reduction	Patients were considered to have effective pain relief ("Yes") if their VAS score remained ≤3 throughout the monitoring period without requiring rescue analgesia.	12 hours

Collaborators and Investigators

• Sponsor: Muhammad Aamir Latif
• Investigators: Principal Investigator: Saima Noreen, Quid-e-Azam Medical College, Bahawalpur; Principal Investigator: Ambreen Khan, Quid-e-Azam Medical College, Bahawalpur; Principal Investigator: Qazi Anees, Quid-e-Azam Medical College, Bahawalpur

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Actual): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Amino Acids, Peptides, and Proteins; Organic Chemicals; Hydrocarbons; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Acids, Acyclic; Carboxylic Acids; Amines; Amino Acids; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Carbocyclic; Cyclohexanecarboxylic Acids; Phenylacetates; Gabapentin; Diclofenac
• Other Study ID Numbers: DR-SAIMA-QAMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data can be shared on a reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No