Preemptive Oral Gabapentin and Tramadol on Postoperative Pain After Knee Arthroscopy

Not Applicable

Completed

• Conditions: Gabapentin; Tramadol; Postoperative Pain; Knee Arthroscopy; Spinal Anesthesia
• Interventions: Drug: Gabapentin; Drug: Tramadol

• Registration Number: NCT06112223
• Lead Sponsor: Tanta University

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.

Detailed Description

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

Study Timeline

• Study Start: 2023-04-01
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01
• Study First Submitted: 2023-10-26
• Study First Submitted QC: 2023-10-26
• Study First Posted: 2023-11-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gabapentin	Gabapentin	Patients will receive oral gabapentin 600 mg 1 hour before the surgery.
Tramadol	Tramadol	Patients will receive oral tramadol 100 mg 1 hour before the surgery.

Primary Outcome Measures

Name	Time	Method
The intensity of postoperative pain	24 hours postoperatively	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.

Secondary Outcome Measures

Name	Time	Method
The incidence of side effects	24 hours postoperatively	Any undesirable side effects during the first 24 hours will be recorded such as as nausea, vomiting \&hypotension.
The time first rescue analgesia	24 hours postoperatively	Rescue analgesia in the form of 3 mg of IV morphine will be given if the visual analog scale (VAS) score≥ 4.
The total amount of morphine consumption in the first 24-hour postoperative	24 hours postoperatively	Rescue analgesia in the form of 3 mg of IV morphine will be given if the visual analog scale (VAS) score\> 3.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt