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

NCT07064993 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2026-05-14

No results posted yet for this study

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.

Conditions

  • Knee Arthroscopy
  • Postoperative Pain

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.

Sponsors & Collaborators

  • Arzu Esen Tekeli

    lead OTHER

Principal Investigators

  • Şükran Sevimli, PhD · Van Yuzuncu Yil University Ethics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07064993 on ClinicalTrials.gov