Van Yuzuncu Yil University School of Medicine Department of Anesthesiology and Reanimation
Van, 65100, Turkey (Türkiye)
NCT Number: NCT07064993
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.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Phase 4
Van, 65100, Turkey (Türkiye)
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. VAS at 0 hour is measured only when Ramsay Sedation Score ≤3. Total irrigation volume (L) is recorded.Intraoperative analgesia is standardized: fentanyl 1 mcg/kg at induction, additional 0.5 mcg/kg as needed (max 3 mcg/kg total). All patients receive IV paracetamol 15 mg/kg before extubation. Total intraoperative fentanyl dose is recorded.
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). Rescue analgesia will be administered as IV dexketoprofen 50 mg if VAS ≥4. Pain will be reassessed after 30 minutes; if VAS remains ≥4, a second dose may be administered. The minimum interval between doses will be 30 minutes, with a maximum total dose of 150 mg within 24 hours. Total dexketoprofen consumption will be recorded. Secondary outcomes include time to first analgesic requirement, total analgesic consumption within 24 hours, and the incidence and severity 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 will be included, while major reconstructive procedures (e.g., anterior cruciate ligament reconstruction) will be excluded.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients aged 18-65 years ASA physical status I-II Scheduled for elective knee arthroscopy under general anesthesia Only minor arthroscopic procedures such as partial meniscectomy will be included Ability to provide informed consent
Exclusion criteria
Allergy or contraindication to tramadol or dexamethasone Chronic opioid use or chronic pain conditions History of psychiatric or neurological disorders that may affect pain perception Severe hepatic or renal impairment Pregnancy or breastfeeding Infection at the injection site Bleeding diathesis Refusal to participate Major reconstructive knee surgeries (e.g., anterior cruciate ligament reconstruction)
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.
Time frame: 0, 2, 6, 12, 24 hours postoperatively
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: Within 24 hours postoperatively
Time from the end of surgery to the first rescue analgesic administration will be recorded in minutes.
Time frame: 24 hours postoperatively
Total rescue analgesic (deksketoprofen) consumption during the first 24 hours after surgery will be recorded in milligrams.
Time frame: 24 hours postoperatively
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
The number of postoperative vomiting episodes will be recorded within the first 24 hours after surgery.
Time frame: 24 hours postoperatively
Itching 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
Shivering severity assessed using a 0-3 scale (0: none, 1: mild, 2: moderate, 3: severe) within the first 24 hours postoperatively.
Time frame: Up to 30 days postoperatively
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.
Contact information is provided by the study sponsor or research team.
Arzu Esen Tekeli, MD
CONTACT
Doğukan Çatulay, MD
CONTACT
Arzu Esen Tekeli
Other
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
Acronym: KATD-PAIN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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