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A Single Preoperative Dose of Gabapentin to Decreases Postoperative Pain in Ambulatory Anal Surgeries

Sponsor
Minia University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05533684
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
3
Anticipated Duration (Months)
16.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Single dose 600 mg gabapentin will be given preoperatively in anal surgeries

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Detailed Description

Patients will be grouped into 2 groups of 25 patients each, the first group will receive 600 mg of gabapentin one hour before surgery and the second group will receive a placebo tablet. pain scores will be measured postoperatively

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
2 groups are included in the study2 groups are included in the study
Masking:
Double (Participant, Investigator)
Masking Description:
double-blinded study both participant and investigator are blind to the study drug
Primary Purpose:
Supportive Care
Official Title:
A Single Preoperative Dose of Gabapentin to Decreases Postoperative Pain in Ambulatory Anal Surgeries
Actual Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
No Intervention: postoperative pain

Measuring postoperative pain using the visual analogue scale
Other: total analgesic consumption

Recording the total amount of analgesia consumed by the patients

Drug: Gabapentin
single preoperative dose of 600 mg gabapentin
Other Names:
  • Gaptin 600 mg

    		•

    Outcome Measures

    Primary Outcome Measures

    1. postoperative pain [first 12 hours postoperative]

      measuring postoperative pain using the visual analog scale from 0 to 10, where zero is the least, and 10 is the worst pain

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. ASA physical status I or II

    2. Aged from 18 to 65 years

    3. Scheduled for anal surgeries at Minya University Hospital

    Exclusion Criteria:

    1. Presence of contraindications to neuraxial anesthesia

    2. Presence of history of central nervous system or mental disorders, epilepsy, chronic pain, or drug abuse.

    3. The use of neuropathic analgesic or antiepileptic drugs

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sarah Omar Minya Egypt 61111

    Sponsors and Collaborators

    • Minia University

    Investigators

    • Principal Investigator: Sarah Omar, M.D., Minia University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sarah Mohamed Aly Omar Mousa, principal investigator, Minia University
    ClinicalTrials.gov Identifier:
    NCT05533684
    Other Study ID Numbers:
    • 343-2022
    First Posted:
    Sep 9, 2022
    Last Update Posted:
    Sep 9, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Sarah Mohamed Aly Omar Mousa, principal investigator, Minia University
    anal surgery,
    gabapentin,
    postoperative pain
    Additional relevant MeSH terms:
    Pain, Postoperative
    Gabapentin

    Study Results

    No Results Posted as of Sep 9, 2022