Interscalene Single Shot With Plain Bupivacaine Versus Liposomal Bupivacaine for Arthroscopic Shoulder Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Average worst pain score with movement over 3 days
研究概览
简要总结
The investigators will be comparing pain scores and opioid use in patients receiving interscalene peripheral blocks with plain bupivacaine versus those receiving liposomal bupivacaine. Liposomal bupivacaine is described as releasing local anesthetic up to 72 hours after its injection; therefore if liposomal bupivacaine can provide extended pain relief compared to plain bupivacaine, the investigators can consider using it as our primary local anesthetic. As secondary outcomes, the investigators will also be looking at difference in functional status and long-term differences between the two local anesthetics.
详细描述
Background:
The current standard of care for patients at the investigators' institution is to perform an interscalene peripheral nerve block for patients receiving arthroscopic shoulder surgery surgery as it is an effective opioid-free alternative for post-operative pain control. The investigators in the past perform both single shot injections and place catheter based on patient and surgical preferences. Catheters have shown to have extended benefit throughout the perioperative period, including lower pain scores, reduced analgesics and improved sleep. However, the negatives of catheters include the placement of a foreign body, increased time to perform the procedure, interference in surgical field and increased cost of catheter equipment and local anesthetic pump and premature catheter dislodgement. Therefore, pros and cons of deciding between placing a single shot injecting versus catheter has to be considered individually for each case.
Liposomal bupivacaine due to its liposomal outer layers, releases bupivacaine over a longer period of time than plain bupivacaine. A pharmacokinetic study showed the terminal half-life of bupivacaine to be 131 ± 58 minutes versus 1294 ± 860 minutes for liposomal bupivacaine.
In a recent study comparing liposomal bupivacaine to placebo for interscalene peripheral nerve blocks, patients receiving liposomal bupivacaine had significantly lower pain scores over 48 hours and received less opioid over 72 hours[6]. Therefore, if a single shot injection with liposomal bupivacaine can provide longer pain relief than plain bupivacaine, it makes the decision to perform single shot interscalene peripheral nerve blocks easier.
Study Objectives The investigators would like to study whether an interscalene peripheral block injection with liposomal bupivacaine provides superior pain control compared to an interscalene single shot with plain bupivacaine. The investigators will be looking at average daily pain scores, highest daily visual analog scale (VAS) pain scores at rest and with movement, total daily opioid consumption from immediately post-operative to 7 days post-operative, and functionality with physical therapy. The investigators will also plan to follow these patients 6 month and 12 months post-operative to determine whether there is any difference in incidence of persistent post-operative pain.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The participants and data collectors are unaware of which group the patient belongs to. The anesthesiologist performing the nerve block will not be blinded.
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
- •medically optimized patients that will undergo an elective surgery for arthroscopic shoulder surgery
排除标准
- •under 18 years pregnant or breast-feeding, non-English speaking, have renal or hepatic dysfunction, history of chronic opioid use, receiving worker's compensation, smoker, receiving capsular release, respiratory compromise or BMI < 18 or > 35 or allergy to local anesthetics or opioids
研究组 & 干预措施
Bupivacaine
Patients in group A will receive a bolus injection with 20 mL of 0.5% bupivacaine.
干预措施: Bupivacaine Hydrochloride (Drug)
Liposomal bupivacaine
Group B will receive 10 mL of 133 mg of liposomal bupivacaine mixed with 10 mL 0.5% bupivacaine.
干预措施: Bupivacaine liposome (Drug)
结局指标
主要结局
Average worst pain score with movement over 3 days
时间窗: 3 days post-operative
The investigators will assess the patients worst pain score each day with movement up to 3 days post-operative. Pain will be assessed using the visual analog scale (VAS) with 0 indicating no pain and 10 indicating worst pain.
次要结局
- Functional Assessment with Physical Therapy(Up to 1 month post-operative)
- Average worst pain score with movement over 7 days(7 days post-operative)
- Total opioid use over 3 days(3 days post-operative)
- Total opioid use over 7 days(7 days post-operative)
- Adverse events(7 days)
- Risk of persistent post-operative pain at 6 months & 12 months(6 months, 12 months)
研究者
Gligor Gucev
Professor
University of Southern California