This study is a prospective, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the postoperative analgesic effects of intraarticular tramadol and tramadol combined with dexamethasone in patients undergoing knee arthroscopy. 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 of the study is postoperative pain intensity assessed by the Visual Analog Scale (VAS). 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.
Postoperative pain remains a significant concern following knee arthroscopy, even in minimally invasive procedures. Various intraarticular agents have been investigated to improve postoperative analgesia, reduce opioid consumption, and enhance patient comfort. Tramadol, a centrally acting analgesic with additional peripheral effects, has been shown to provide analgesia when administered intraarticularly. Dexamethasone, a corticosteroid with anti-inflammatory properties, may enhance analgesic efficacy when used as an adjuvant. This study is a prospective, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the postoperative analgesic effects of intraarticular tramadol and tramadol combined with dexamethasone in patients undergoing elective knee arthroscopy. A total of 120-135 patients aged 18-65 years with ASA physical status I-II scheduled for knee arthroscopy under general anesthesia will be included. Patients will be randomly assigned into three groups in a 1:1:1 ratio using a computer-generated block randomization method. At the end of the surgical procedure, after aspiration of the irrigation fluid and before closure of the portal, the study solutions will be administered intraarticularly in a standardized volume of 20 mL. The groups will be as follows: placebo (normal saline), tramadol (100 mg), and tramadol (100 mg) combined with dexamethasone (8 mg). All study solutions will be prepared by an independent investigator in identical syringes to ensure blinding of patients, surgeons, anesthesiologists, and outcome assessors. All patients will receive standardized general anesthesia and postoperative analgesia protocols. Pain intensity will be assessed using the Visual Analog Scale (VAS) at predetermined time points (0, 2, 6, 12, and 24 hours postoperatively). Rescue analgesia will be administered when VAS ≥ 4, and total analgesic consumption will be recorded. The primary outcome of the study is postoperative pain intensity assessed by the Visual Analog Scale (VAS) at 0, 2, 6, 12, and 24 hours postoperatively. 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, shivering, and potential complications. This study aims to determine whether intraarticular tramadol provides effective postoperative analgesia and whether the addition of dexamethasone enhances this effect, thereby contributing to improved postoperative pain management strategies in knee arthroscopy.To ensure procedural homogeneity, only minor arthroscopic procedures such as partial meniscectomy and diagnostic arthroscopy will be included, while major reconstructive procedures (e.g., anterior cruciate ligament reconstruction) will be excluded.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
135
20 mL of normal saline administered intraarticularly at the end of surgery.
Tramadol 100 mg diluted with saline to a total volume of 20 mL, administered intraarticularly at the end of surgery.
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.
Van Yuzuncu Yil University School of Medicine Department of Anesthesiology and Reanimation
Van, Turkey (Türkiye)
Postoperative pain intensity (VAS score)
Pain intensity will be assessed using a 0-10 Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Measurements will be obtained at 0, 2, 6, 12, and 24 hours postoperatively.
Time frame: 0, 2, 6, 12, and 24 hours postoperatively
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
Total analgesic consumption
Total rescue analgesic consumption during the first 24 hours after surgery will be recorded in milligrams.
Time frame: 24 hours postoperatively
Nausea incidence
The presence of postoperative nausea will be recorded within the first 24 hours after surgery.
Time frame: 24 hours postoperatively
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
Itching incidence
The presence of postoperative itching will be recorded within the first 24 hours after surgery.
Time frame: 24 hours postoperatively
Shivering incidence
The presence of postoperative shivering will be recorded within the first 24 hours after surgery.
Time frame: 24 hours postoperatively
Adverse events
Adverse events will be recorded as follows: nausea, vomiting, itching, and shivering within the first 24 hours postoperatively; and joint infection within 30 days postoperatively.
Time frame: Up to 30 days postoperatively
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