NCT07064993

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

A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial Evaluating the Effects of Intraarticular Tramadol and Tramadol Plus Dexamethasone on Postoperative Pain After Knee Arthroscopy

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: Arzu Esen Tekeli · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Knee Arthroscopy
• Postoperative Pain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-05-29
• Primary completion: 2027-02-26
• Completion: 2027-04-30
• First posted: 2025-07-15
• Last updated: 2026-04-15

Locations

1 site across 1 country: Turkey (Türkiye)