Preemptive Oral Gabapentin and Tramadol on Postoperative Pain After Knee Arthroscopy

NCT ID: NCT06112223

Last Updated: 2024-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2023-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Orthopedic surgeries are frequently associated with moderate-to-severe postoperative pain that can decrease mobility in the immediate postoperative period, interfere with postoperative rehabilitation, and delay hospital discharge. Pain may also become chronic.

Spinal anesthesia is the most popular anesthesia technique worldwide in orthopedic lower limb surgeries. However, its relatively short duration of action may limit the excellent postoperative analgesic effect. Thus, many adjuvants had been used to improve postoperative analgesia and decrease consumption of postoperative analgesics.

Gabapentin is a gamma aminobutyric acid analogue that is known as an anticonvulsant drug. This drug is tolerated well and has known effects on pain and anxiety.

Tramadol, a commonly used postoperative analgesic, is a synthetic centrally acting opioid analgesic. The various actions include inhibition of noradrenaline and serotonin reuptake, and also inhibition of M1 and M3 muscarinic receptors

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gabapentin Tramadol Postoperative Pain Knee Arthroscopy Spinal Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Gabapentin

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

Group Type EXPERIMENTAL

Gabapentin

Intervention Type DRUG

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

Tramadol

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

Group Type EXPERIMENTAL

Tramadol

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Gabapentin

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

Intervention Type DRUG

Tramadol

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tanta University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Laila Elahwal

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tanta University

Tanta, El-Gharbia, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

36264PR151/3/23

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Ketamine Effects as Preemptive Analgesia
NCT06040060 COMPLETED PHASE2/PHASE3
Naproxen Codeine in Arthroscopic Surgery
NCT01952652 COMPLETED PHASE4