NCT07131527

Brief Summary

this study amis to compare between perioperative oral Gabapentin versus Diclofenac sodium on postoperative analgesia patients undergoing laparoscopic cholecystectomy

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

July 14, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 13, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 20, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2026

Completed
Last Updated

August 20, 2025

Status Verified

August 1, 2025

Enrollment Period

6 months

First QC Date

August 13, 2025

Last Update Submit

August 13, 2025

Conditions

Cholecystitis, Chronic

Outcome Measures

Primary Outcomes (1)

  • the effect of preoperative oral Gabapentin versu Diclofenac sodium in adult patient undergoing laparoscopic cholecystectomy

    postoperative pain by Numerical Rating Scale (0 represents "no pain" while 10 represents "the worst pain)

    8 hours after operation

Study Arms (2)

group A will receive oral Gabapentin

ACTIVE COMPARATOR

Patients included in this group will receive 600 mg of gabapentin 2 h before surgery.

Drug: Gabapentin

group B will receive diclofenac sodium

ACTIVE COMPARATOR

Patients included in this group will receive 100 mg diclofenac sodium 2 h before surgery.

Drug: Diclofenac Sodium

Interventions

GabapentinDRUG

oral Gabapentin will be given 2 hours perioperative as postoperative analgesia patients undergoing laparoscopic cholecystectomy

group A will receive oral Gabapentin
Diclofenac SodiumDRUG

oral diclofenac sodium will be given 2 hours perioperative as postoperative analgesia patients undergoing laparoscopic cholecystectomy

group B will receive diclofenac sodium

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age from 20 to 60 years old. Both sexes. American Society of Anesthesiologists (ASA) physical status I- II. Patients undergoing laparoscopic cholecystectomy.

You may not qualify if:

  • Patients with hypertension. Pregnant women. Obese patients with BMI \>35 kg/m2. Alcoholics. Patients With DM Patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university hospital

Sohag, Egypt

RECRUITING

Related Publications (3)

  • Abuahmed M, Rashid R. Day-case laparoscopic cholecystectomy in the management of gallbladder disease: a literature review. Langenbecks Arch Surg. 2024 Sep 28;409(1):292. doi: 10.1007/s00423-024-03479-6.

    PMID: 39340655BACKGROUND

  • Nestor CC, Ng C, Sepulveda P, Irwin MG. Pharmacological and clinical implications of local anaesthetic mixtures: a narrative review. Anaesthesia. 2022 Mar;77(3):339-350. doi: 10.1111/anae.15641. Epub 2021 Dec 14.

    PMID: 34904711BACKGROUND

  • LaForge JM, Urso K, Day JM, Bourgeois CW, Ross MM, Ahmadzadeh S, Shekoohi S, Cornett EM, Kaye AM, Kaye AD. Non-steroidal Anti-inflammatory Drugs: Clinical Implications, Renal Impairment Risks, and AKI. Adv Ther. 2023 May;40(5):2082-2096. doi: 10.1007/s12325-023-02481-6. Epub 2023 Mar 22.

    PMID: 36947330BACKGROUND

MeSH Terms

Conditions

CholecystitisBronchiolitis Obliterans Syndrome

Interventions

GabapentinDiclofenac

Condition Hierarchy (Ancestors)

Gallbladder DiseasesBiliary Tract DiseasesDigestive System DiseasesOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Manar Z Ismaiel, Resident

CONTACT

01027233046manorzakaria90@gmail.com

Ahmed E Abdel Rahman, Professor

CONTACT

01118011611

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident , Anesthesia , Surgical Icu , Pain management Faculty of Medicine Sohag university

Study Record Dates

First Submitted

August 13, 2025

First Posted

August 20, 2025

Study Start

July 14, 2025

Primary Completion

January 20, 2026

Study Completion

January 20, 2026

Last Updated

August 20, 2025

Record last verified: 2025-08

Locations

EG(1)