A Novel Application of Exparel for Postoperative Pain Management in Shoulder Arthroplasty and Humerus Fracture Fixation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Quality of Analgesia
研究概览
简要总结
The purpose of this study is to compare the effect of liposomal Bupivacaine infiltration into the shoulder to continues nerve block with Bupivacaine on postoperative pain control and functional outcomes.
详细描述
liposomal bupivacaine analgesia will provide improved postoperative pain control, reduction in amount of opioid supplementation, decreased complications and faster return to function compared to current standard of care pain management for patients undergoing shoulder arthroplasty and shoulder surgery for proximal humerus fractures.
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
- •Patients undergoing shoulder arthroplasty under general anesthesia
- •Patients undergoing open reduction internal fixation (ORIF) of a proximal humerus fracture under general anesthesia
- •Patients with American Society of Anesthesiologist (ASA) physical status classification of 1-3
- •Patients meeting criteria for standard of care continuous peripheral nerve block (CPNB) per anesthesia guidelines.
- •Patients agreeing to be available for brief follow up telephone survey post- operatively and being mentally able to respond.
- •Patients available for follow up routine post-operative clinic visits, per standard of care.
排除标准
- •Contraindications to regional anesthesia
- •Significant peripheral neuropathy or neurological disorder affecting the upper extremity
- •Contraindication to a component of multimodal analgesia
- •Pregnancy
- •Opioid tolerance
- •Cognitive or psychiatric condition that might affect patient assessment and/or inability to provide informed consent.
研究组 & 干预措施
Liposomal Bupivacaine A
One time injection of 1.3% Liposomal Bupivacaine during shoulder arthroplasty
干预措施: 1.3% Liposomal Bupivacaine (Drug)
CISB control for A
Peripheral nerve block (CISB) with 0.125% bupivacaine during shoulder arthroplasty .
干预措施: 0.125% Bupivacaine (Drug)
Liposomal Bupivacaine B
One time injection of 1.3% Liposomal Bupivacaine during Humerus Fracture Fixation
干预措施: 1.3% Liposomal Bupivacaine (Drug)
CISB control for B
Peripheral nerve block (CISB) with 0.125% bupivacaine during fracture fixation
干预措施: 0.125% Bupivacaine (Drug)
结局指标
主要结局
Quality of Analgesia
时间窗: 30 days
Quality of analgesia as measured by numerical rating scores for pain (active and at rest) as (0=no pain, 10= worst pain) every two hours for the initial 36 hours, then on day2, day7 and day30 postoperatively
次要结局
- Post Operative American Shoulder and Elbow Surgeons (ASES)(Preoperative, 6 weeks and last follow up)
- Incidence of Nerve Injury(During hospital stay and at 2 weeks and 6 weeks post-operatively)
- Post Operative Opioid Consumption(During hospital stay up to 48 hours after surgery)
- Subjective Shoulder Value (SSV)(Pre-operative, 6 weeks and last Follow up)
研究者
Vani J. Sabesan
Associate Professor
Wayne State University