Postoperative Pain Control After Enucleation or Evisceration, a Double-Masked Randomized Controlled Trial of Standard Versus Slow-release Bupivacaine
试验速览
- 阶段
- 4 期
- 状态
- 进行中(未招募)
- 发起方
- Mayo Clinic
- 入组人数
- 88
- 试验地点
- 4
- 主要终点
- Postoperative orbital pain
研究概览
简要总结
After surgery to remove the eye, either by enucleation or evisceration, patients have variable levels of pain for several postoperative days. Some patients have almost no discomfort while others require significant amounts of oral narcotics and report pain of 10 out of 10 on a numerical rating scale. The current operative standard is to infiltrate the eye socket with 0.5% bupivacaine during surgery leading to several hours of postoperative analgesia. In 2011, Pacira Pharmaceuticals released a bupivacaine liposomal injectable suspension (Exparel, 1.3%) which offers sustained release of bupivacaine giving postoperative pain control for up to 72 hours. This medication has been used in numerous surgeries including inguinal hernia repair, hemorrhoidectomy, bunionectomy, breast reconstruction, and orthopedic surgery, and the literature reports improved pain control, decreased use of oral opioids, and increased patient satisfaction. There are no reports of the use of Exparel in the ophthalmic literature. The investigators propose a randomized, controlled trial to compare the postoperative pain control offered by sustained release bupivacaine to that offered by standard plain bupivacaine after enucleation or evisceration.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •All patients undergoing enucleation or evisceration of the eye whose surgery is performed by the Department of Ophthalmology at Mayo Clinic Rochester
- •Willing and able to comprehend a numerical rating scale system and provide a score to assess pain, nausea, and satisfaction level.
排除标准
- •Age less than 18 years (Exparel has not been tested in a pediatric population)
- •Pregnant or nursing (Exparel has not been tested in this patient population)
研究组 & 干预措施
Plain bupivacaine
Intraoperative injection of local anesthetic agent, standard of care
干预措施: Bupivacaine (Drug)
Exparel (sustained release bupivacaine)
Intraoperative injection of local anesthetic agent, long acting agent
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Postoperative orbital pain
时间窗: Days 3 postoperatively
Pain on a scale of 0-10, assessed on day 3 post enucleation or evisceration
次要结局
- Postoperative nausea and vomiting(Days 3 postoperatively)
- Quantity of oral narcotics used for postoperative pain control(Days 3 postoperatively)
- Patient satisfaction(Day 3 postoperatively)
- Postoperative complications(6-8 weeks postoperatively)
