A Randomized Comparison Between Interscalene and Costoclavicular Infraclavicular Brachial Plexus Blocks For Arthroscopic Shoulder Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Static pain at 30 minutes after arrival in the PACU
研究概览
简要总结
Interscalene brachial plexus block constitutes the analgesic criterion standard for shoulder surgery. However, it is associated with a high incidence of hemidiaphragmatic paralysis (HDP) that may not be tolerated by patients with chronic pulmonary disease. This randomized controlled trial (RCT) will compare ultrasound-guided interscalene block (ISB) and costoclavicular infraclavicular block (CCICB) in patients undergoing arthroscopic shoulder surgery.
The main outcome is static pain at 30 minutes after arrival in the post anesthesia care unit (PACU) as measured by a numerical rate scale (NRS) from 0 to 10. Our research hypothesis is that interscalene and costoclavicular infraclavicular blocks will result in equivalent postoperative analgesia at 30 minutes in the PACU. The equivalence margin is set at 2 points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing arthroscopic shoulder surgery
- •American Society of Anesthesiologists classification 1-3
- •Body mass index between 20 and 35
排除标准
- •Adults who are unable to give their own consent
- •Pre-existing neuropathy
- •Coagulopathy
- •Obstructive or restrictive pulmonary disease
- •Renal failure
- •Hepatic failure
- •Allergy to local anesthetics
- •Pregnancy
- •Prior surgery in the corresponding side of the neck or infraclavicular fossa
- •Chronic pain syndromes requiring opioid intake at home
研究组 & 干预措施
Interscalene Block
Patients randomized to receive an intesrcalene block.
干预措施: Interscalene Block (Procedure)
Costoclavicular Infraclavicular Block
Patients randomized to receive a costoclavicular infraclavicular block.
干预措施: Costoclavicular Infraclavicular Block (Procedure)
结局指标
主要结局
Static pain at 30 minutes after arrival in the PACU
时间窗: 30 minutes
Evaluated with a NRS from 0 to 10
次要结局
- Procedural pain during blocks(1 hour before surgery)
- Surgical duration(Intraoperative period)
- Incidence of HDP at 30 minutes after interscalene or costoclavicular infraclavicular block(30 minutes post injection)
- Block performance time(1 hour before surgery)
- Block- and opioid-related side effects(1 week)
- Patient satisfaction(24 hours after surgery)
- Postoperative static pain at 2 hours(2 hours)
- Onset time(1 hour before surgery)
- Intraoperative opioid requirements(Intraoperative period)
- Static pain at 60 minutes after arrival in the PACU(60 minutes)
- Postoperative static pain at 3 hours(3 hours)
- Postoperative static pain at 6 hours(6 hours)
- Postoperative static pain at 12 hours(12 hours)
- Postoperative static pain at 24 hours(24 hours)
- Sensory and Motor block score(30 minutes post injection)
- Incidence of HDP at 30 minutes after arrival to PACU(30 minutes after arrival to the PACU)
- Incidence of complete block(30 minutes post injection)
- Postoperative opioid consumption(24 hours after surgery)
研究者
Julian Aliste
Clinical Instructor, Department of Anesthesia
University of Chile