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临床试验/NCT02365181
NCT02365181已完成4 期

A Randomized Controlled Non-inferiority Trial Between the Intra-articular Local Anesthetic Infiltration With Catheter and Interscalene Block With Catheter in Postoperative Analgesia After Shoulder Prosthesis

Hospital Ambroise Paré Paris5 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2014年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
98
试验地点
5
主要终点
Mean postoperative pain

研究概览

简要总结

The control of perioperative pain is necessary to avoid worst surgical suites after shoulder arthroplasty. Interscalene block (ISB) with or without catheter is the gold standard in postoperative analgesia after shoulder prosthesis but neurological or respiratory adverse events can occured . The intra-articular local (IAL) anesthetic infiltration with catheter is a simple procedure. Its efficacy was proved in knee and hip arthroplasty but not in shoulder arthroplasty. Our hypothesis was the IAL is as effective as ISB in early postoperative analgesia after shoulder arthroplasty.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Shoulder arthroplasty
  • Osteoarthritis

排除标准

  • Previous surgery in the same shoulder

研究组 & 干预措施

IAL

Experimental

intra-articular local anesthetic infiltration with catheter

干预措施: intra-articular local anesthetic infiltration (Procedure)

IAL

Experimental

intra-articular local anesthetic infiltration with catheter

干预措施: Ropivacaine 2 % (Drug)

ISB

Active Comparator

interscalene block with catheter

干预措施: inter-scalene block (Procedure)

ISB

Active Comparator

interscalene block with catheter

干预措施: Ropivacaine 2 % (Drug)

结局指标

主要结局

Mean postoperative pain

时间窗: during the 48 first hours

次要结局

  • Complications dues to anesthesia procedure(At 12 hours after surgery)

研究者

发起方
Hospital Ambroise Paré Paris
申办方类型
Other
责任方
Principal Investigator
主要研究者

Shahnaz Klouche, MD

Physician responsible of clinical research

Hospital Ambroise Paré Paris

研究点 (5)

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