A Prospective Trial to Assess Analgesic Efficacy of Liposomal Bupivacaine vs. Bupivacaine HCL as a Tap Block After Abdominally Based Autologous Breast Reconstruction
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Opioid Use During Hospital Stay
研究概览
简要总结
This study will evaluate the efficacy of analgesia provided by liposomal bupivacaine (Exparel) when compared to bupivacaine HCL as a transverse abdominis plane (TAP) block in terms of discharge milestones, opioid use, costs, and patient-reported satisfaction at 12, 24, and 72 hours. The investigators propose that Exparel will lower opioid use, length of stay, and overall cost of abdominally-based autologous breast reconstruction, and will lead to greater 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
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Scheduled for abdominal-based autologous breast reconstruction (DIEP, MS-TRAM, or TRAM).
- •At least 18 years of age.
- •Able to understand and willing to sign a written informed consent document.
排除标准
- •Cognitive impairment.
- •History of abdominal surgery precluding free flap donor site.
- •Allergy or intolerance to bupivacaine or "amide" anesthetics.
- •Significant preoperative chronic pain (requiring daily narcotics) or neuropathic pain (requiring daily use of pregabalin or gabapentin) within the previous 3 months.
- •Pregnant or breastfeeding.
研究组 & 干预措施
Group 1: Bupivicaine
-TAP block of 30 cc of 0.25% bupivicaine
干预措施: Bupivicaine HCL (Drug)
Group 2: Liposomal bupivacaine
-TAP block of 266 mg/30 cc liposomal bupivacaine
干预措施: Liposomal bupivacaine (Drug)
结局指标
主要结局
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Opioid Use During Hospital Stay
时间窗: Up to day of discharge from hospital (expected hospital stay of 5 days)
次要结局
- Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Antiemetic Use During the Hospital Stay(Up to day of discharge from hospital (expected hospital stay of 5 days))
- Cost of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl When Accounting for Length of Hospital Stay and Use of Other Analgesics(Up to 2 weeks post-operation)
- Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Length of Hospital Stay(Up to day of discharge from hospital, up to 7 days)
- Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores(72 hours after surgery)
- Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Time Until Ambulation(Up to 2 weeks post-operation)
- Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Duration of Urinary Catheter(Up to 2 weeks post-operation)
- Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Change From Baseline in Patient Satisfaction With Recovery(At post operative day 2, discharge, and at 1-2 week follow-up)