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NOT YET RECRUITING
NCT07064993
PHASE4

Effects of Intraarticular Tramadol and Tramadol-Dexamethasone on Postoperative Pain After Knee Arthroscopy

Sponsor: Arzu Esen Tekeli

View on ClinicalTrials.gov

Summary

Patients scheduled for elective knee arthroscopy under general anesthesia will be randomly assigned into three groups in a 1:1:1 ratio: placebo (saline), tramadol, and tramadol plus dexamethasone. At the end of surgery, after aspiration of the irrigation fluid, the study solution will be administered intraarticularly in a standardized volume. The primary outcome is the area under the curve (AUC) of VAS scores measured at 0, 2, 6, 12, and 24 hours postoperatively (VAS AUC 0-24h). Secondary outcomes include time to first analgesic requirement, total analgesic consumption within 24 hours, and the incidence of adverse effects such as nausea, vomiting, itching, and shivering. This study aims to determine whether intraarticular tramadol provides effective postoperative analgesia and whether the addition of dexamethasone enhances this analgesic effect.

Official title: A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial Evaluating the Effects of Intraarticular Tramadol and Tramadol Plus Dexamethasone on Postoperative Pain After Knee Arthroscopy

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

135

Start Date

2026-07-15

Completion Date

2027-04-30

Last Updated

2026-05-14

Healthy Volunteers

No

Interventions

DRUG

Saline

20 mL of normal saline administered intraarticularly at the end of surgery.

DRUG

Tramadol

Tramadol 100 mg diluted with saline to a total volume of 20 mL, administered intraarticularly at the end of surgery.

DRUG

Tramadol + Dexamethasone

Tramadol 100 mg combined with dexamethasone 8 mg diluted with saline to a total volume of 20 mL, administered intraarticularly at the end of surgery.

Locations (1)

Van Yuzuncu Yil University School of Medicine Department of Anesthesiology and Reanimation

Van, Turkey (Türkiye)