Gabapentin and Diclofenac Sodium Comparison for Post-Operative Pain Relief

NCT ID: NCT07267182

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2023-02-28

Brief Summary

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.

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gabapentin group

Patients received a single oral dose of gabapentin 600 mg one hour before surgery.

Group Type: EXPERIMENTAL

Gabapentin 600mg

Intervention Type: DRUG

Patients received a single oral dose of gabapentin 600 mg one hour before surgery.

Diclofenac group

Patients were given a single oral dose of diclofenac sodium 100 mg one hour before surgery.

Group Type: EXPERIMENTAL

Diclofenac Sodium 100 MG

Intervention Type: DRUG

Patients were given a single oral dose of diclofenac sodium 100 mg one hour before surgery.

Interventions

Gabapentin 600mg

Patients received a single oral dose of gabapentin 600 mg one hour before surgery.

Intervention Type: DRUG

Diclofenac Sodium 100 MG

Patients were given a single oral dose of diclofenac sodium 100 mg one hour before surgery.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Muhammad Aamir Latif

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Aamir Latif

Research Consultant

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Saima Noreen

Role: PRINCIPAL_INVESTIGATOR

Quid-e-Azam Medical College, Bahawalpur

Ambreen Khan

Role: PRINCIPAL_INVESTIGATOR

Quid-e-Azam Medical College, Bahawalpur

Qazi Anees

Role: PRINCIPAL_INVESTIGATOR

Quid-e-Azam Medical College, Bahawalpur

Locations

Bahawal Victoria Hospital

Bahawalpur, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

DR-SAIMA-QAMC

Identifier Type: -

Identifier Source: org_study_id