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

ConditionsKnee ArthroscopyPostoperative Pain
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorArzu Esen Tekeli

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Saline

    Drug

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

  • Tramadol

    Drug

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

  • Tramadol + Dexamethasone

    Drug

    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.

Treatment groups

135 Participants
are divided into 3 treatment groups
Group A: Placebo GroupPlacebo comparator 1 intervention
Group B: Tramadol GroupExperimental treatment 1 intervention
Group C: Tramadol + Dexamethasone GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative pain intensity - Area Under the Curve (VAS AUC 0-24 hours)

Pain intensity is assessed using a 0-10 Visual Analog Scale (VAS) at 0, 2, 6, 12, and 24 hours postoperatively. The primary outcome is the area under the curve (AUC) calculated from these five time points using the trapezoidal rule. AUC represents the total pain burden over the first 24 hours.

Time frame
0, 2, 6, 12, 24 hours postoperatively

Secondary outcomes

1

Time to first analgesic requirement

Time from the end of surgery to the first rescue analgesic administration will be recorded in minutes.

Time frame
Within 24 hours postoperatively
2

Total analgesic consumption

Total rescue analgesic (deksketoprofen) consumption during the first 24 hours after surgery will be recorded in milligrams.

Time frame
24 hours postoperatively
3

Postoperative nausea severity (0-3 scale)

Nausea severity assessed using a 0-3 scale (0: none, 1: mild, 2: moderate, 3: severe) within the first 24 hours postoperatively.

Time frame
24 hours postoperatively
4

Number of vomiting episodes

The number of postoperative vomiting episodes will be recorded within the first 24 hours after surgery.

Time frame
24 hours postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Arzu Esen Tekeli

Lead sponsor

Yuzuncu Yil University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: