跳至主要内容
临床试验/NCT02381353
NCT02381353进行中(未招募)4 期

Postoperative Pain Control After Enucleation or Evisceration, a Double-Masked Randomized Controlled Trial of Standard Versus Slow-release Bupivacaine

Mayo Clinic4 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2015年2月1日最近更新:
适应症
干预措施

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

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

Active Comparator

Intraoperative injection of local anesthetic agent, standard of care

干预措施: Bupivacaine (Drug)

Exparel (sustained release bupivacaine)

Experimental

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)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elizabeth A. Bradley, M.D.

PI

Mayo Clinic

研究点 (4)

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