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

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

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Gabapentin

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Minya, Egypt, 61111
    • Sarah Omar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain	measuring postoperative pain using the visual analog scale from 0 to 10, where zero is the least, and 10 is the worst pain	first 12 hours postoperative

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: September 3, 2022
• First Submitted That Met QC Criteria: September 7, 2022
• First Posted (Actual): September 9, 2022

Study Record Updates

• Last Update Posted (Actual): March 16, 2023
• Last Update Submitted That Met QC Criteria: March 15, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: postoperative pain; anal surgery,; gabapentin,
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin
• Other Study ID Numbers: 343-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The research will be available to other researchers when it is completed

Drug and device information, study documents

• 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