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

Sponsor
Arzu Esen Tekeli
Study ID
NCT07064993
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Knee Arthroscopy
  • Postoperative Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Jul 15, 2025
Start date
Jul 15, 2026
Status verified
May 2026
Primary completion
Feb 26, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
135 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo Group
    Patients will receive 20 mL of normal saline administered intraarticularly at the end of surgery.
  • Experimental: Tramadol Group
    Patients will receive 100 mg tramadol diluted with saline to a total volume of 20 mL, administered intraarticularly at the end of surgery.
  • Experimental: Tramadol + Dexamethasone Group
    Patients will receive 100 mg tramadol combined with 8 mg dexamethasone diluted with saline to a total volume of 20 mL, administered intraarticularly at the end of surgery.

Primary Outcome Measure

Postoperative pain intensity - Area Under the Curve (VAS AUC 0-24 hours) [ Time Frame: 0, 2, 6, 12, 24 hours postoperatively ]

Central Contacts

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