Interscalene Block Versus Superior Trunk Block: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Number of Participants With Incidence of Hemidiaphragmatic Paralysis (HDP)
研究概览
简要总结
Sparing the phrenic nerve by administering ultrasound-guided low volume superior trunk block (STB) and interscalene block (ISB) for arthroscopic shoulder surgery (labral repair, stabilization, rotator cuff repair).
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
- Triple (Participant, Investigator, 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 who will be undergoing primary unilateral labral repair/stabilization of the shoulder
- •Age 18 to 80 years
- •Planned use of general anesthesia with LMA and interscalene or superior trunk block
- •Ability to follow study protocol
- •English speaking
- •ASA I - III
排除标准
- •Pre-existing neuropathy of the operative limb
- •Younger than 18 years old and older than 80
- •Patients with pulmonary severe respiratory disease
- •Allergy to one of the study medications
- •Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
- •Chronic opioid use (taking opioids for longer than 3 months)
- •Contraindication to general anesthesia, interscalene or superior trunk block
- •Herniated Cervical Disk, Cervical Myelopathy
研究组 & 干预措施
interscalene block (ISB)
The interscalene block will be done using an ultrasound-guided, in-plane approach. The anesthesiologists will target below the C5 nerve root. A 22 gauge 1.5-2 inch needle is advanced in-plane from lateral to medial through the middle scalene muscle until the needle tip is positioned in the interscalene groove between the C5 and C6 nerve roots. 15 20 ml of 0.5% bupivacaine will be injected.
干预措施: Bupivacaine (Drug)
interscalene block (ISB)
The interscalene block will be done using an ultrasound-guided, in-plane approach. The anesthesiologists will target below the C5 nerve root. A 22 gauge 1.5-2 inch needle is advanced in-plane from lateral to medial through the middle scalene muscle until the needle tip is positioned in the interscalene groove between the C5 and C6 nerve roots. 15 20 ml of 0.5% bupivacaine will be injected.
干预措施: Ultrasound (Device)
superior trunk block (STB)
The superior trunk block will be performed at the point immediately distal to the roots when the c5-c6 form the superior trunk and lies anterior to the middle scalene muscle and below the deep cervical fascia, before the suprascapular nerve arises and goes into the omohyoid. A 22g 1.5-2inch needle will be advanced in-plane from lateral to medial. The needle tip will be placed lateral to the superior trunk and 15 20 ml of 0.5% bupivacaine will be injected just inferior to the deep cervical fasica. Local circumferential spread will be achieved both anterior and posterior to the superior trunk.
干预措施: Bupivacaine (Drug)
superior trunk block (STB)
The superior trunk block will be performed at the point immediately distal to the roots when the c5-c6 form the superior trunk and lies anterior to the middle scalene muscle and below the deep cervical fascia, before the suprascapular nerve arises and goes into the omohyoid. A 22g 1.5-2inch needle will be advanced in-plane from lateral to medial. The needle tip will be placed lateral to the superior trunk and 15 20 ml of 0.5% bupivacaine will be injected just inferior to the deep cervical fasica. Local circumferential spread will be achieved both anterior and posterior to the superior trunk.
干预措施: Ultrasound (Device)
结局指标
主要结局
Number of Participants With Incidence of Hemidiaphragmatic Paralysis (HDP)
时间窗: Day of Surgery, diagnosis confirmed from trained anesthesiologist ultrasound readers
Our primary outcome will be the incidence of hemidiaphragmatic paralysis (HDP) with superior trunk block and interscalene blocks as measured by ultrasound before and after the surgery.
Numerical Pain Rating System (NRS) Pain Scores
时间窗: Average pain scores at rest recorded Day of Surgery every 30 minutes until discharge according to Post Anaesthetic Discharge Scoring System
Numerical Pain Rating System Pain scores after the superior trunk block and interscalene block at rest measured after the surgery every 30 minute until discharge according to the Post Anaesthetic Discharge Scoring System. Numerical Rating Scale 0-10; with 0 being no pain and 10 pain as bad as you can imagine.
次要结局
- Block Duration(Time of block wearing off recorded on Post Operative Day 1 and Post Operative Day 2 as reported via patient phone call.)