NCT07267182

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 5, 2025

Completed
Last Updated

December 5, 2025

Status Verified

November 1, 2025

Enrollment Period

7 months

First QC Date

November 24, 2025

Last Update Submit

November 24, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Gabapentin group

EXPERIMENTAL

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

Drug: Gabapentin 600mg

Diclofenac group

EXPERIMENTAL

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

Drug: Diclofenac Sodium 100 MG

Interventions

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

Gabapentin group

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

Diclofenac group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahawal Victoria Hospital

Bahawalpur, Punjab Province, 63100, Pakistan

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

GabapentinDiclofenac

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and ProteinsPhenylacetates

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Consultant

Study Record Dates

First Submitted

November 24, 2025

First Posted

December 5, 2025

Study Start

August 1, 2022

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

December 5, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Data can be shared on a reasonable request.

Locations