Preoperative Interscalene Nerve Block Plus Postoperative Local Intra-operative Analgesic Injection vs Preoperative Interscalene Nerve Block Plus Postoperative Saline Injection in Patients Undergoing Shoulder Arthroplasty: a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- morphine and morphine equivalent consumption
研究概览
简要总结
This study is a non-blinded randomized controlled trial comparing the use of a preoperative "mini" block plus postoperative local infiltration of Exparel (liposomal form of bupivacaine) versus a partial single shot nerve block in subjects undergoing primary reverse or total shoulder arthroplasty to see which is more effective in controlling surgery related pain. To do so, we will utilize the Visual Analog Scale (VAS) to measure pain intensity. Opioid consumption will be recorded on a Pain Monitoring Sheet.
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
- None
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
- •All individuals undergoing primary reverse and total shoulder arthroplasty by the shoulder service at Thomas Jefferson University Hospital, Methodist Hospital or Rothman Specialty Hospital.
排除标准
- •Psychiatric illness as defined by co-morbid diagnosis of bipolar disorder or schizophrenia
- •Revision arthroplasty or arthroplasty for fracture
- •Unable/unwilling to consent for enrollment
- •Unable to complete postoperative pain survey
- •Known adverse drug reaction or allergy to the medications used
- •Chronic pain syndromes (including reflex sympathetic dystrophy, fibromyalgia, chronic diffuse musculoskeletal pain)
- •Patients taking long acting opioid pain medications (including extended release opioid pain medications and methadone)
- •Patients under the age of 18 years
- •Patients with history of hepatic disease
- •Pregnant or breastfeeding women.
研究组 & 干预措施
Preoperative block plus saline
Preoperative interscalene brachial plexus single-shot block using 25ml of 0.5% Ropivicaine plus postoperative 40cc local infiltration of saline
干预措施: Saline (Drug)
Preoperative block plus Bupivacaine extended-release liposome
Interscalene brachial plexus single shot block preoperatively (25 ml of 0.5% ropivicaine) + Postoperative Infiltration of local anesthetic/analgesic (20 cc Bupivacaine extended-release liposome injection (Exparel) + Diluted in 20cc of Saline into the capsule, subscapularis, deltoid, pectoralis major and subcutaneous tissues)
干预措施: Bupivacaine liposome (Drug)
结局指标
主要结局
morphine and morphine equivalent consumption
时间窗: 24 hours post surgery
次要结局
未报告次要终点