Randomized Controlled Trial of Supraclavicular Bupivacaine Vs. Supraclavicular Liposomal Bupivacaine for Orthopedic Wrist Surgery
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pre-operative and 48-hour Post-operative Quality of Recovery 15 survey score
研究概览
简要总结
Orthopedic wrist procedures often cause significant postoperative pain. A supraclavicular nerve block is an effective and proven method to help reduce postoperative pain and decrease opioid use around the time of upper extremity surgery. Liposomal bupivacaine (Exparel) has been approved for use around the brachial plexus, but its analgesic efficacy has limited data. The investigators' goal is to evaluate the effectiveness of Exparel as compared to plain bupivacaine. The investigators hope to ensure the quality of pain control around the time of distal radius fracture repair and reduce the variability of care at the investigators institution by prospectively and rigorously collecting perioperative data during this study.
详细描述
Purpose: Orthopedic wrist procedures often cause significant postoperative pain. A supraclavicular nerve block is an effective and proven method to help reduce postoperative pain and decrease opioid use around the time of shoulder surgery. Liposomal bupivacaine (Exparel) has been approved for use around the brachial plexus, but its analgesic efficacy has limited data. The investigators goal is to evaluate the effectiveness of Exparel as compared to the investigators prior standard practice of using plain bupivacaine. The investigators hope to ensure the quality of pain control around the time of distal radius fracture repair and reduce the variability of care at the investigators institution by prospectively and rigorously collecting perioperative data during this study.
Participants: Adult participants age > 18 undergoing orthopedic wrist surgery at the University of North Carolina ambulatory surgery center and University of North Carolina Hillsborough campus Exclusion Criteria: the below are simply contraindications to regional anesthesia in general, this is a pragmatic study to evaluate the quality of care for these subjects with no additional exclusion criteria.- Contraindications to regional anesthesia- Significant peripheral neuropathy or neurological disorder affecting the upper extremity- Pregnancy- Cognitive or psychiatric condition that might affect patient assessment and/or inability to provide informed consent.
Procedures (methods): This is a prospective, randomized comparison of participants undergoing orthopedic wrist procedures that receive one of two types of supraclavicular nerve block. Group 1 will be comprised of patients with a preoperative supraclavicular nerve block placed with 20 mL 0.5% bupivacaine. Group 2 will be comprised of participants with a preoperative supraclavicular nerve block placed with 10 mL 0.5% bupivacaine and 10 mL 1.3% Liposomal Bupivacaine (Exparel). All subjects in both groups will have a similar intraoperative general anesthetic with multimodal analgesic pre-op oral medications. Outcomes measured by Post anesthesia care unit assessment and telephone follow up: see uploaded data collection form.
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, Investigator)
盲法说明
As participants are enrolled in this study, a study identification will be created as their basic demographic information is entered into the secure RedCap database. At this time, the RedCap randomization tool will randomize the subject to either group 1 or 2.
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
- •Age greater than or equal to 18
- •Scheduled for orthopedic wrist surgery at University of North Carolina at Chapel Hill.
排除标准
- •Contraindications to regional anesthesia
- •Emergent surgery Open fractures will be treated emergently and will not allow adequate lead time for enrollment in this study. Also, open fractures are usually accompanied by other traumatic injuries that would confound the pain related outcomes in this study.
- •Significant peripheral neuropathy or neurological disorder affecting the upper extremity
- •Pregnancy Pregnant women have physiologic changes that make them more sensitive to local anesthetics. That would introduce a confounding element in interpreting the effectiveness of the peripheral nerve blocks being studied.
- •Cognitive or psychiatric condition that might affect patient assessment and/or inability to provide informed consent.
研究组 & 干预措施
Supraclavicular Liposomal Bupivacaine group
This group will receive the liposomal bupivacaine
干预措施: Liposomal bupivacaine (Drug)
Supraclavicular Plain Bupivacaine group
This group will receive the plain bupivacaine
干预措施: Bupivacaine Hydrochloride (Drug)
结局指标
主要结局
Pre-operative and 48-hour Post-operative Quality of Recovery 15 survey score
时间窗: Pre-operative and at 24 hours and 48 hours post-operative
The quality of recovery-15 (QoR-15) is a validated questionnaire to assess postoperative recovery. Scale is based on 15 questions, each question score range is 0-10 (0 being poor and 10 being excellent) The survey will be conducted at 24 hours intervals after surgery up to 48 hours total after surgery. The total score range is 0-150, where a score of 0 would be the worst possible score, and 150 would be the best possible score
次要结局
- Time to First Dose of Opioid Medication(Post-operative period up to 48 hours after surgery)
- Total opioid dose through Post-op Day 2(Post-operative period up to 48 hours after surgery)
- Difference in Participant Reported Pain Scores(Post-operative period up to 48 hours after surgery)