Pecs II Block Versus Surgeon Infiltration for Open Subpectoral Biceps Tenodesis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Opioid Utilization for the First 24 Hours After Surgery
研究概览
简要总结
A phase IV, randomized, single-blind, single-center study measuring the effects of Pecs II block with 0.25% bupivacaine versus surgeon infiltration with 0.25% bupivacaine on postoperative pain control and opioid utilization in participants who undergo open subpectoral tenodesis.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18 and 75 years of age
- •Patients undergoing shoulder arthroscopy with open subpectoral biceps tenodesis
排除标准
- •Patients younger than 18 and older than 75;
- •Patients with a history of chronic pain that have used opioids for pain management for 3 months or longer;
- •Patients who are allergic to oxycodone;
- •Patients with diagnosed or self-reported cognitive dysfunction;
- •Patients with a history of neurologic disorder that can interfere with pain sensation;
- •Patients with a history of drug or recorded alcohol abuse;
- •Patients who are unable to understand or follow instructions;
- •Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease;
- •Patients with an allergy or contraindication to any of the medications used in the study, or patients with a contraindication to any study procedures;
- •Patients with a BMI over 45;
- •Any patient that the investigators feel cannot comply with all study related procedures;
- •NYU Langone Health students, residents, faculty or staff members.
研究组 & 干预措施
Pecs II block
80 patients scheduled for open biceps tenodesis
干预措施: Bupivacaine 20mL 0.5% (Drug)
Pecs II block
80 patients scheduled for open biceps tenodesis
干预措施: Bupivacaine 20mL 0.25% (Drug)
Surgical infiltration
80 patients scheduled for open biceps tenodesis
干预措施: Bupivacaine 20mL 0.5% (Drug)
Surgical infiltration
80 patients scheduled for open biceps tenodesis
干预措施: Bupivacaine up to 15mL 0.25% (Drug)
结局指标
主要结局
Opioid Utilization for the First 24 Hours After Surgery
时间窗: Up to 24-Hours Post-Operation
Opioid utilization is calculated as morphine milligram equivalents (MME); measurement includes opioid utilization during surgery.
次要结局
- Patient-reported Numerical Rating Scale (NRS) Score in Post Anesthesia Care Unit (PACU)(Typically 1-3 Hours Post-Operation)
- Patient-reported Numerical Rating Scale (NRS) Score(Day 3 Post-Operation)
- Number of Patients With Reactions to Surgical Subpectoral Incision - Movement(Intraoperative)
- Number of Patients With Reactions to Surgical Subpectoral Incision - Tachycardia(Intraoperative)
- Number of Patients With Reactions to Surgical Subpectoral Incision - Sensation in Bicep(Intraoperative)