Quality of Analgesia After Interscalene Block With Bupivacaine and Exparel® vs. Bupivacaine Alone After Arthroscopic Shoulder Surgery
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
- 2
- 主要终点
- Satisfaction with analgesia
研究概览
简要总结
Shoulder arthroscopic causes post operative pain that outlasts analgesia provided by single injection nerve blocks.
详细描述
The interscalene brachial plexus block (ISBPB) is a common analgesic technique for procedures of the shoulder and upper arm.
Moreover, the incidence of rebound pain is well documented and is often of considerable discomfort to patients, who may quickly go from little or no pain to moderate-severe pain. Continuous nerve block techniques with home ambulatory catheters are currently utilized to manage postoperative pain.This study is designed to compare the level and duration of pain control of Exparel® injected after bupivacaine via stop-cock connected syringes and bupivacaine alone for ISBPB.
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)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dutch or English speaking adults
- •18 years or older ASA I-III physical class
- •Scheduled for elective arthroscopic shoulder surgery
排除标准
- •History of allergy to a local anesthetic
- •Baseline neurological deficit
- •Medical condition that would make it difficult to assess sensory distribution or communicate with the investigators' staff
- •Recent history (< 3 months) of drug or alcohol abuse
- •Concomitant opioid therapy
- •Preexisting coagulation disorder
- •Infection at the injection site
- •Pregnancy
研究组 & 干预措施
Exparel block in arthroscopic surgery
Evaluation of Exparel block in arthroscopic shoulder surgery.
干预措施: Exparel block in arthroscopic shoulder surgery (Drug)
Bupivacaine block in shoulder surgery
Evaluation of Bupivacaine block in shoulder surgery.
干预措施: Bupivacaine block in shoulder surgery (Drug)
结局指标
主要结局
Satisfaction with analgesia
时间窗: assessed by the Overall Benefit of Analgesia Score (OBAS) in the first postoperative week postoperative day (POD)1 through POD7
Worst pain
时间窗: assessed by the Modified Brief Pain Inventory short form Question 1 in the first postoperative week - postoperative day (POD) 1 through POD7
次要结局
- Onset of sensory block(onset will be measured up to 30 minutes)
- Duration of sensory block(duration will be measured up to 72 hours)
- Onset of motor block(onset will be measured up to 30 minutes)
- duration of motor block(duration will be measured up to 72 hours)
- functionality of the surgical arm(assessed on the scale 0-5 in the first postoperative week - postoperative day (POD) 2- POD7)