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临床试验/NCT01151241
NCT01151241已完成不适用

Outpatient Versus Inpatient Continuous Brachial Plexus Block for Complex Arthroscopic Elbow Surgery: Safety and Functional Outcome

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Range of Motion

研究概览

简要总结

Patients undergoing elbow arthroscopy surgery will receive standard anesthesia and analgesia (infraclavicular nerve block combined with general anesthesia for surgery; continuous infusion via infraclavicular catheter to day 3 post op). Patients in the experimental group will be discharged home after one day, with infraclavicular catheter in place; patients in the comparator group will stay in hospital for 3 or 4 days, per standard practice. The study will compare range of motion as the primary endpoint, in a non-inferiority design, to see if early discharge is feasible while providing similar recovery.

研究设计

研究类型
Interventional
分配方式
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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients undergoing elective complex arthroscopic elbow surgery requiring postoperative CPM - synovectomy, capsulectomy, extensive debridement, contracture release, osteocapsular arthroplasty.
  • •ASA I-III

排除标准

  • •Cognitively challenged patients
  • •Severe COPD
  • •Patients who, on their own or with the assistance of a caregiver, are not confident of being able to remove the local anesthetic infusion catheter at home
  • •Psychiatric history
  • •Allergy to ropivacaine.
  • •Opioid tolerance (>60mg oral morphine or equivalent/day)

研究组 & 干预措施

Early discharge

Experimental

Patients will be discharged home on the first day after surgery, with infraclavicular catheter infusion of local anesthetic in place.

干预措施: Elbow arthroscopy with infraclavicular nerve block and continuous local anesthetic infusion to day 3 post op. (Procedure)

Early discharge

Experimental

Patients will be discharged home on the first day after surgery, with infraclavicular catheter infusion of local anesthetic in place.

干预措施: Early Discharge (Other)

Normal Discharge

Active Comparator

Patients will remain in hospital and be discharged per current discharge criteria, once the infraclavicular catheter has been removed on day 3 post op. Typical discharge occurs on day 3 or 4 post op.

干预措施: Elbow arthroscopy with infraclavicular nerve block and continuous local anesthetic infusion to day 3 post op. (Procedure)

Normal Discharge

Active Comparator

Patients will remain in hospital and be discharged per current discharge criteria, once the infraclavicular catheter has been removed on day 3 post op. Typical discharge occurs on day 3 or 4 post op.

干预措施: Normal Discharge (Other)

结局指标

主要结局

Range of Motion

时间窗: 1 year

Range of motion at the elbow will be measured vs. baseline to determine surgical success.

次要结局

  • Post-operative analgesia(3 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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