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

NCT05533684 | Completed Early Phase 1

• 1 other identifier: 343-2022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain, Postoperative

Keywords

anal surgery,; gabapentin,; postoperative pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

postoperative pain

NO INTERVENTION

Measuring postoperative pain using the visual analogue scale

total analgesic consumption

OTHER

Recording the total amount of analgesia consumed by the patients

Drug: Gabapentin

Interventions

Gabapentin DRUG

single preoperative dose of 600 mg gabapentin

Also known as: Gaptin 600 mg

total analgesic consumption

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status I or II
• Aged from 18 to 65 years
• Scheduled for anal surgeries at Minya University Hospital

You may not qualify if:

• Presence of contraindications to neuraxial anesthesia
• Presence of history of central nervous system or mental disorders, epilepsy, chronic pain, or drug abuse.
• The use of neuropathic analgesic or antiepileptic drugs

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Sarah Omar

Minya, 61111, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Sarah Omar, M.D.

  Minia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blinded study both participant and investigator are blind to the study drug
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 2 groups are included in the study

Study Record Dates

• First Submitted: September 3, 2022
• First Posted: September 9, 2022
• Study Start: September 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)