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
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
- 否
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
intra-articular local anesthetic infiltration with catheter
干预措施: intra-articular local anesthetic infiltration (Procedure)
IAL
intra-articular local anesthetic infiltration with catheter
干预措施: Ropivacaine 2 % (Drug)
ISB
interscalene block with catheter
干预措施: inter-scalene block (Procedure)
ISB
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
Shahnaz Klouche, MD
Physician responsible of clinical research
Hospital Ambroise Paré Paris
