Interscalene Block With and Without Liposomal Bupivacaine in Shoulder Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Opiate Consumption
研究概览
简要总结
The purpose of this study is to examine the difference in perioperative pain after shoulder surgery with a standard bupivacaine nerve block compared to liposomal bupivacaine enhanced nerve block alone in TSA and ARCR. Data will be compared using VAS scores and opiate consumption between the two groups. The hypothesis of this study is that an interscalene nerve block with liposomal bupivacaine will decrease both postoperative VAS pain scores and total narcotic consumption when compared to a standard bupivacaine interscalene nerve block alone.
详细描述
Arthroscopic rotator cuff repair (ARCR) and shoulder arthroplasty (TSA) provide excellent clinical outcomes but are often associated with significant postoperative pain, frequently managed with oral opioid medication. Orthopedic surgeons prescribe approximately 32 unused pills per shoulder surgery and are the third largest prescribers of opiates in the USA. It is incumbent upon the orthopedic community to identify postoperative pain management methods which reduce the need for narcotic medication following shoulder procedures as a means to mitigate the impact of orthopedic procedures on this epidemic.
The use of intraoperative local and regional anesthesia or field blocks, in conjunction with multimodal pharmacological strategies, is an accepted approach for managing surgical pain and reducing opiate use but requires peer reviewed protocols to gain wider acceptance.
Interscalene nerve block with bupivacaine remains a gold standard for peri-operative analgesia, but is associated with significant rebound pain due to the short duration of the local anesthetics. Recent studies have demonstrated that the addition of a liposomal bupivacaine field block may lower pain and enhance patient satisfaction throughout the first postoperative week. Liposomal bupivacaine has recently received FDA approval for ISB, but the data regarding its efficacy in nerve blocks is sparse.
The purpose of this pilot study is to determine if liposomal bupivacaine-enhanced interscalene nerve blocks can be used to improve peri-operative pain control methods, limit narcotic use, and provide appropriate postoperative analgesia compared to standard bupivacaine blocks. Primary and secondary outcome measures will be collected as number of opiates taken and self-reported VAS pain scores over a 14 day postoperative period, respectively.
The hypothesis of this study is that an interscalene nerve block with liposomal bupivacaine will decrease both postoperative VAS pain scores and total narcotic consumption when compared to a standard bupivacaine interscalene nerve block alone.
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
- 否
入选标准
- •Patients over 18 undergoing rotator cuff repair or total shoulder arthroplasty
排除标准
- •Documented drug of alcohol abuse
- •Active narcotic use prior to surgery
- •Neurological deficit
- •Allergy to amide anesthetics
- •Not cleared by primary care physician
- •Hydrocodone or oxycodone intolerance
- •Enrollment in another clinical trial or past cognitive or mental health status that interferes with study
研究组 & 干预措施
Liposomal Bupivacaine Interscalene Block
Liposomal bupivacaine anesthetic will be administered as an interscalene block during rotator cuff repair surgery and total shoulder arthroplasty.
干预措施: Liposomal Bupivacaine (Drug)
结局指标
主要结局
Opiate Consumption
时间窗: Post-operative days 1-14
Total amount of narcotics consumed during the postoperative period, measured in morphine equivalents (OME)
次要结局
- Likert Pain Satisfaction Rating(Post operative days 1-14)
- VAS Pain Scores(Post operative days 1-14)
研究者
Paul Sethi
Principal Investigator
Orthopaedic & Neurosurgery Specialists