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
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Postoperative pain measurement
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All study solutions will be prepared by an independent investigator and administered in identical syringes. Patients, surgeons, anesthesiologists, and outcome assessors will be blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Placebo Group
Patients will receive 20 mL of normal saline administered intraarticularly at the end of surgery.
干预措施: Saline (Drug)
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.
干预措施: Tramadol + Dexamethasone (Drug)
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.
干预措施: Tramadol (Drug)
结局指标
主要结局
Postoperative pain measurement
时间窗: 3 hours interval
Visual Analogue Scale scores (0 to 10, 0:no pain, 10 worst)
Postoperative pain intensity - Area Under the Curve (VAS AUC 0-24 hours)
时间窗: 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.
次要结局
- Time to first analgesic requirement(Within 24 hours postoperatively)
- Number of vomiting episodes(24 hours postoperatively)
- Adverse events(Up to 30 days postoperatively)
- Total analgesic consumption(24 hours postoperatively)
- ıntraoperative and post operative effects except VAS scores(3 hours interval)
- Postoperative nausea severity (0-3 scale)(24 hours postoperatively)
- Postoperative itching severity (0-3 scale)(24 hours postoperatively)
- Postoperative shivering severity (0-3 scale)(24 hours postoperatively)
研究者
Arzu Esen Tekeli
Associate Professor of Anesthesiology
Yuzuncu Yil University