2024-510789-17-00招募中4 期
Perioperative oral analgesia versus intravenous analgesia for knee arthroscopy, a randomized, double-blinded, non-inferiority trial. OVIKA-trial - S68618
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- UZ Leuven
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- The primary endpoint will be the mean postoperative pain scores measured with the Numeric Rating Scale (NRS) during for minor knee arthroscopy, measured once preoperatively and at different time points postoperatively up to discharge
研究概览
简要总结
Evaluating the analgesic effect of oral versus intravenous analgesics postoperative
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Follow- up
- 盲法
- Double (Subject, Carer, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Minor knee surgery under general anaesthesia, including arthroscopic meniscectomy and synovectomy, diagnostic arthroscopy, meniscus repair and arthroscopic lavage.
- •>=18 years of age
- •ASA 1-3 suitable for ambulatory surgery
- •Voluntary written informed consent of the participant
- •Dutch speaking
排除标准
- •History of liver diseases, renal insufficiency, epilepsy, allergy to paracetamol or ibuprofen
- •Any disorder which, in the Investigator's opinion, might jeopardize the participant's safety or compliance with the protocol
- •Any prior or concomitant treatment(s) that might jeopardize the participant's safety or that would compromise the integrity of the Trial.
- •Participation in an interventional Trial with an investigational medicinal product (IMP) or device.
- •A contraindication for the use of paracetamol or ibuprofen
- •Non-compliance of the patient
- •postive urine pregnancy test in women of childbearing potential
结局指标
主要结局
The primary endpoint will be the mean postoperative pain scores measured with the Numeric Rating Scale (NRS) during for minor knee arthroscopy, measured once preoperatively and at different time points postoperatively up to discharge
The primary endpoint will be the mean postoperative pain scores measured with the Numeric Rating Scale (NRS) during for minor knee arthroscopy, measured once preoperatively and at different time points postoperatively up to discharge
次要结局
- Key-secondary: - The need (number of patients) for postoperative rescue medication (morphine or clonidine) and time to readiness for discharge
- Timepoint-specific NRS for pain during the hospital stay
- NRS for pain 4h after discharge
- NRS for pain 24h after discharge
- Mean dose of opioid rescue medication (mean calculated per patient)
- Presence of Post-Operative Nausea and Vomiting (PONV) (at least once)
- Number of times emetics were used after discharge until 24 hours postop
- Analgesic use during the first 24 hours
- Economic evaluation
- Quality of Recovery-40 questionnaire
研究者
department of Anesthesiology
Scientific
UZ Leuven
研究点 (1)
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