drugset / Trial / NCT07064993

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

NCT07064993

Phase 4 Not yet recruiting 135 enrolled Arzu Esen Tekeli
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2026-07-15
Primary completion
2027-02-26
Completion
2027-04-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 8 mg Other
Subject Tramadol Other / unclassified 100 mg Other

Indications

No indication recorded.