Randomized Trial Comparing Interscalene Nerve Block to Liposomal Bupivacaine For Pain Management Following Reverse Total Shoulder Arthroplasty (RTSA)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Patient Satisfaction: Rating
研究概览
简要总结
The aim of this study is to compare two different pain management interventions in patients undergoing reverse total shoulder arthroplasty. The two interventions are 1) pre-operative interscalene nerve block and 2) intraoperative injection of liposomal bupivacaine (Exparel, Pacira Pharmaceuticals, Parsippany NJ). Specifically, the primary aims of this study are to compare these two interventions on the following: post-operative opioid consumption, pain scores, and patient satisfaction. Additionally, the investigators want to determine if psychological factors, catastrophizing and resilience, are associated with post-operative pain control and satisfaction. The investigators' hypothesis is that the two interventions will have similar pain control efficacy and that the liposomal bupivacaine group will experience faster post-operative recovery, earlier discharge, and improved satisfaction. The investigators also expect patient catastrophizing and resilience to significantly predict the degree of post-operative pain and level of patient satisfaction.
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
- None
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
- •patients who are older than 18 years
- •patients undergoing reverse total shoulder arthroplasty
排除标准
- •pregnancy
- •inability to provide informed consent
- •deemed unreliable for follow-up survey completion
- •individuals who do not speak English
- •those who have an allergy to the study medications (ropivicaine, bupivicaine) or have clinically significant hepatic disease
研究组 & 干预措施
Liposomal Bupivacaine
Patients in this group will receive a single intra-operative injection of liposomal bupivacaine near the surgical site (40 ml total: consisting of 20 ml 1.3% liposomal bupivacaine and 20 ml normal saline).
干预措施: Exparel (Drug)
Interscalene Nerve Block
Patients in this group will receive a single pre-operative interscalene nerve block in the neck/shoulder consisting of 30 ml 0.5% ropivacaine.
干预措施: Interscalene Nerve Block (Procedure)
结局指标
主要结局
Patient Satisfaction: Rating
时间窗: 72 hours post-operatively
Rating of satisfaction with post-operative pain management from 0 (least satisfied) to 10 (most satisfied)
Relationship between resilience, pain, and patient satisfaction
时间窗: Resilience will be measured pre-operatively
The effect of patient resilience (measured using the Brief Resilience Scale) on post-operative pain control and satisfaction. The Brief Resilience Scale measures how individuals psychologically respond to pain and hardship, and it ranges from a minimum score of 1 to a maximum score of 5. Higher scores on the Brief Resilience Scale indicate greater resilience. The patients' resilience scores will be correlated with their post-operative pain scores and their satisfaction scores. A correlation closer to -1 or 1 (correlations range from -1 to 1) indicates a stronger relationship between resilience with pain control and satisfaction.
Opioid Consumption
时间窗: 72 hours post-operatively
Post-operative use of opioid pain medications, measured in morphine equivalents (higher scores are worse)
Visual Analog Scale Pain Scores
时间窗: 72 hours post-operatively
Post-operative level of pain measured from 0 (no pain) to 10 (worst pain)
Relationship between catastrophizing, pain, and patient satisfaction
时间窗: Catastrophizing will be measured pre-operatively
The effect of patient catastrophizing (measured using the Pain Catastrophizing Scale) on post-operative pain control and satisfaction. The Pain Catastrophizing Scale measures how individuals psychologically respond to pain and hardship, and it ranges from a minimum score of 0 to a maximum score of 52. Higher scores on the Pain Catastrophizing Scale indicate more catastrophic thinking. The patients' catastrophizing scores will be correlated with their post-operative pain scores and their satisfaction scores. A correlation closer to -1 or 1 (correlations range from -1 to 1) indicates a stronger relationship between catastrophizing with pain control and satisfaction.
次要结局
未报告次要终点
研究者
Adam Schumaier
Principal Investigator
University of Cincinnati