NCT01385449终止不适用
Continuous Interscalene Block (CISB) Versus Single Injection Interscalene Block in Those Undergoing Shoulder Surgery in the Ambulatory Setting
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 73
- 试验地点
- 4
- 主要终点
- pain on post-operative day 1
研究概览
简要总结
The primary hypothesis is that those patients who choose an interscalene catheter will have less pain postoperatively than those with single injection blocks. Secondary hypotheses examine physical therapy outcomes and incidence of parasthesia or pain following surgery for up to 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status 1-3
- •18-79 years of age, inclusive
- •body mass index of < 36 kg/m
- •The ability to understand local anesthetic related complications and care of a CPNB
- •Presence of a caretaker with them during the first 24 hours of local anesthetic infusion, and on a daily basis.
- •The ability to communicate with the practitioner managing the catheter.
- •Residence within 2 hours of University of Wisconsin Hospital and Clinics
排除标准
- •Any contraindication to a continuous interscalene catheter placement
- •Clinically significant pulmonary disease
- •Clinically significant cardiac disease
- •Allergy to ropivacaine
- •Peripheral or central nervous system disease
- •Current (or planned) anticoagulation therapy or disease
- •Local infection over area of catheter placement
- •Renal or hepatic failure
- •History of opioid dependence
- •Significant psychiatric disease
- •Pregnancy or lactation (Subjects will be asked if it is possible they could be pregnant. If a subject responds in the affirmative, a pregnancy test will be done.)
- •Seizure Disorder
研究组 & 干预措施
interscalene block
Experimental
interscalene block
干预措施: interscalene block (Procedure)
interscalene catheter
Experimental
interscalene catheter
干预措施: interscalene catheter (Procedure)
结局指标
主要结局
pain on post-operative day 1
时间窗: 24 hours
Pain score on post-operative day 1(POD1) using numeric rating scale (NRS)
次要结局
- Pain post operative day 2 (POD2)(48 hours)
研究者
研究点 (4)
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