Catheter-based peripheral regional anaesthesia after orthopaedic surgery: Comparison of low dose, automated periodic infusions with conventional high dose, continuous infusion, and patient-initiated infusions only. A non-inferiority, randomised, controlled trial. - Focus on Infusion in Peripheral Regional Anaesthesia

ordsjællands Hospital Hillerød0 个研究点目标入组 270 人开始时间: 2017年7月10日最近更新: 2019年12月10日

适应症

试验速览

暂无简介。

•Substudy one:
•1.=18 years of age
•2.Scheduled for elective shoulder arthroplasty, rotator cuff repair, or Bankart operation
•3.ASA classification24 = III
•4.Agreement to the trial protocol
•Substudy two:
•1) Age = 18 years
•2) American Society of Anesthesiologists Classification I-III
•3) Normal cognitive function in order to sign written, informed consent
•and to understand trial protocol
•4) Agreement to the trial protocol, including the randomized manner
•Substudy three:
•1) Age = 18 years
•2) American Society of Anesthesiologists Classification I-III
•3) Normal cognitive function in order to sign written, informed consent
•and to understand trial protocol
•4) Agreement to the trial protocol, including the randomized manner
•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 180
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 90

•Substudy one:
•1.Body weight = 50 kg
•2.Allergy to local anaesthetics
•3.Mental or cognitive disease that impede compliance
•4.Contraindication of interscalene brachial plexus nerve block (i.e. pneumothorax, severe pulmonary disease)
•5.Anatomic abnormalities preventing successful US-guided Certa Catheter™ insertion.
•6.Pregnancy or breastfeeding
•Substudy two and three:
•1) Allergy to LA
•2) Infection in or near insertion site of the peripheral nerve catheter
•3) Habitual use of opioids
•4) Pregnancy or breastfeeding

发起方

ordsjællands Hospital Hillerød