Preemptive Oral Gabapentin and Tramadol on Postoperative Pain After Knee Arthroscopy

NCT06112223 | Completed

• 1 other identifier: 36264PR151/3/23
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study to evaluate the effect of preemptive oral gabapentin versus tramadol on postoperative pain after knee arthroscopy under spinal anesthesia.

Conditions

Gabapentin; Tramadol; Postoperative Pain; Knee Arthroscopy; Spinal Anesthesia

Outcome Measures

Primary Outcomes (1)

• The intensity of postoperative pain

  Assessment of postoperative pain will be done with a analogue scale (VAS; 0=no pain and 10=worst possible pain). At discharge post-operative and every 2 hours postoperative till 12hours then every 6 hours for the first 24 hours.

  24 hours postoperatively

Secondary Outcomes (3)

• The total amount of morphine consumption in the first 24-hour postoperative

  24 hours postoperatively

• The time first rescue analgesia

  24 hours postoperatively

• The incidence of side effects

  24 hours postoperatively

Study Arms (2)

Gabapentin

EXPERIMENTAL

Patients will receive oral gabapentin 600 mg 1 hour before the surgery.

Drug: Gabapentin

Tramadol

EXPERIMENTAL

Patients will receive oral tramadol 100 mg 1 hour before the surgery.

Drug: Tramadol

Interventions

Gabapentin DRUG

Patients will receive oral gabapentin 600 mg 1 hour before the surgery.

Gabapentin

Tramadol DRUG

Patients will receive oral tramadol 100 mg 1 hour before the surgery.

Tramadol

Eligibility Criteria

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

You may qualify if:

• Age 18-65 years old.
• Both sexes. American Society of Anesthesiologists (ASA) physical status I and II
• Undergoing knee arthroscopy procedures.
• under spinal anesthesia.

You may not qualify if:

• Cardiac patients.
• Patients with known allergy to drug of study.
• Prolonged administration of NSAIDS or other analgesics due to chronic pain of any reason.
• Cirrhosis.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Gabapentin; Tramadol

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; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 1, 2023
• Study Start: April 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: October 2, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)