Ultrasound-guided Interscalene Brachial Plexus Block: Single Bolus Injection Versus Continuous Catheter Placement in Arthroscopic Rotator Cuff Repair-a Prospective Randomized Unblinded Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pain severity
研究概览
简要总结
Shoulder arthroscopy is a minimally invasive procedure frequently used for rotator cuff repair. Patients may experience severe postoperative (PO) pain, that can last for a month and can influence successful rehabilitation. Our study aimes to evaluate the effectiveness of interscalene brachial plexus single-shot (ISBSS) versus continuous interscalene brachial plexus block (ISBC) in controlling perioperative pain and avoiding PO pain chronicization. This prospective randomized unblinded trial hypothesizes that the PO perineuronal infusion using a continuous ambulatory delivery device pump gives better pain control and outcomes than ISBSS during the long-term follow-up period.
详细描述
Blocks will be performed under ultrasound guidance with 15 - 20 mL of 0.75 % ropivacaine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •American Society of Anesthesia (ASA) physical status of 1 to 2,
- •Body Mass Index (BMI) of less than 30 kg/m²,
- •paitents undergoing shoulder arthroscopy for small to medium rotator cuff tears.
排除标准
- •skin infection on the puncture site,
- •coagulopathy
- •brachial plexus neuropathy
- •alcohol or drug abuse
- •severe lung disease
- •history of allergy to one or more study drugs.
研究组 & 干预措施
effectiveness of interscalene brachial plexus single-shot
An ultrasound-guided peripheral nerve block puncture will be performed from the lateral to the medial side of the neck. In this group a 22G 50 mm needle will be used
干预措施: single bolus injection (Procedure)
continuous interscalene brachial plexus block
An ultrasound-guided peripheral nerve block puncture will be performed from the lateral to the medial side of the neck. In this arm, a 22G 50 mm SonoPlex needle with an indwelling cannula will be used.
干预措施: the ISBC group, SonoPlex needle and E-catheter (Procedure)
结局指标
主要结局
Pain severity
时间窗: 24 hour, 48 hour, 72 hour, 7 day
Tha pain severity will be evaluated by NRS scale
次要结局
未报告次要终点
研究者
Cotoia Antonella
Doctor
University of Foggia