Pharmacokinetic Profile of Liposome Bupivacaine (Exparel®) after Perineural Admission in the Interscalene Groove for Primary Total Shoulder Arthroplasty. - KiNEX

Sint Maartenskliniek0 个研究点开始时间: 2015年7月29日最近更新: 2015年9月14日

适应症

试验速览

暂无简介。

•-Age =18 years
•-ASA physical health classification I-II
•-Patient planned for a primary unilateral total shoulder arthroplasty or reversed shoulder arthroplasty under total anesthesia with a locoregional anesthetic block
•-Hb >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

•-BMI (body mass index) >35kg/m2
•-Known hypersensitivity to amide-type local anesthetics
•-Chronic use of opiates
•-Contraindication for paracetamol, NSAID’s or opiates.
•-COPD gold 3-4 or any other pulmonary disease that significantly affects pulmonary function
•-Hepatic or renal insufficiency
•-Use of fluvoxamine, ciproflocaxine, ketoconazol, erytromycine, claritromycine, itraconazol or rifampicine because of their effect on bupivacaine clearance.
•-Inadequate proficiency in Dutch.
•-Any other reason which in the opinion of the investigator makes the patient unsuitable for participation in the study

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