Liposomal Bupivacaine Reduces Opiate Consumption After Rotator Cuff Repair in a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Daily Opioid Consumption in Oral Morphine Equivalent
研究概览
简要总结
The use of an interscalene block (ISB) is often associated with rebound pain that could be avoided through adjunctive therapy with longer duration. Administration of a liposomal bupivacaine (LB) field block in addition to ISB would overcome this rebound pain to provide greater pain relief and reduce opiate consumption when compared to ISB alone. 50 patients were recruited and randomized into groups that either received or did not receive an intraoperative LB field block in addition to standard ISB administration. Visual Analog Scale (VAS) pain scores and narcotic consumption were recorded over the five-day postoperative period to determine the effectiveness of LB pain relief.
详细描述
Arthroscopic rotator cuff repair (ARCR) provides excellent clinical outcomes but is often associated with significant postoperative pain. As rotator cuff repair procedures become increasingly more common, these procedures and the narcotic prescriptions which accompany them may contribute to the rising opioid epidemic. The use of intraoperative local and regional anesthesia or field blocks, in conjunction with multimodal pharmacological strategies, is a widely accepted approach for managing surgical pain and reducing opiate use. The purpose of this study was to determine whether using a field block of liposomal bupivacaine (LB) in addition to an interscalene block (ISB) would provide greater pain relief and reduction in opiate consumption when compared to ISB alone.
The study enrolled 50 patients undergoing primary ARCR surgery. Patients were randomized to receiving intraoperative liposomal bupivacaine or not and provided with postoperative "Pain Journals" to document their daily pain on a visual analog scale (VAS) and to track their daily opioid consumption during the first five post-operative days.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •at least 18 years of age
- •undergoing an arthroscopic rotator cuff repair surgery of a full thickness tear
- •willing to fill out the "Pain Journal"; able to understand the informed consent process
- •willing to document informed consent prior to completion of any study-related procedure
- •able to read, comprehend, and complete subject-reported outcome measures in English
排除标准
- •documented history of drug or alcohol abuse
- •use of narcotic painkillers greater than 3 months prior to surgery
- •neurologic deficit or disability involving the surgical extremity
- •known allergy or intolerance to hydrocodone or oxycodone
- •known allergy to amide anesthetics
- •currently enrolled or planning to enroll in another clinical trial during this study that would affect the outcome of this study
- •history of cognitive or mental health status that interferes with study participation
研究组 & 干预措施
Liposomal Bupivacaine (LB)
Administration of 20 ml of LB diluted with an additional 40 ml of saline was injected into a triangular soft tissue surgical field block, along with standard bupivacaine interscalene block
干预措施: Liposomal bupivacaine (LB) (Drug)
结局指标
主要结局
Daily Opioid Consumption in Oral Morphine Equivalent
时间窗: Post-operative day one to five
Total amount of narcotics consumed over the study period following surgery
次要结局
- Visual Analog Scale Pain Scores(Post-operative day one to five)
研究者
Paul Sethi
Principal Investigator
Orthopaedic & Neurosurgery Specialists