EUCTR2017-000180-32-NL进行中（未招募）1 期
Pharmacokinetic Profile of Ropivacaine after Periarticular Local Infiltration Analgesia for Primary Total Knee Arthroplasty Without the use of a Tourniquet. - LIAkin II
Sint Maartenskliniek Nijmegen0 个研究点目标入组 20 人开始时间: 2017年1月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •-age 50-80 years
- •-ASA physical health classification I – II
- •-Body Mass Index (BMI) < 40
- •-patient planned for a primary unilateral posterior-stabilized tri-compartmental cemented total knee replacement (Genesis II - PS) under unilateral spinal anesthesia with 2 mL hyperbaric bupivacaine 0.5%
- •-scheduled for fast-track protocol TKA
- •-haemoglobin (Hb) concentration = 7.5 mMol/L
- •-written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •-Placement of a surgical drain
- •-Contra-indications for spinal anesthesia
- •-Known hypersensitivity to amide-type local anesthetics
- •-Hepatic or renal insufficiency
- •-Use of fluvoxamine, ciprofloxacin, ketoconazole, erythromycin, clarithromycin, itraconazole, or rifampicin because of their effect on ropivacaine clearance.
- •-Any reason to perform surgery with the use of a tourniquet
- •-Any other reason which in the opinion of the investigator makes the patient unsuitable for participation in the study
研究者
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