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临床试验/NCT01995045
NCT01995045已完成4 期

The Effects of Triamcinolone Acetonide With Retrobulbar Anesthesia on Postoperative Pain Control Following Vitreoretinal Surgery

Emory University1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2012年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
58
试验地点
1
主要终点
Mean Pain Score

研究概览

简要总结

The aim of this study is to evaluate if patients receiving a steroid (triamcinolone acetonide) combined with local anesthesia and antibiotic following retina surgery have better postoperative pain control those receiving local anesthesia and antibiotic alone.

详细描述

Currently, patients undergoing vitreoretinal surgery at the Emory Eye Center and Emory University Hospital receive a injection of local anesthesia behind the eye (retrobulbar) at the start of surgery to minimize discomfort felt during the surgery. At the end of surgery all patients receive a periocular antibiotic and steroid injection. Some patients also receive a retrobulbar injection of local anesthesia (bupivicaine) at the conclusion of surgery in order to decrease postoperative pain and discomfort.

It has been our observation that when the local anesthesia is combined with a steroid (triamcinolone acetonide) in a retrobulbar injection at the conclusion of surgery, patients tend to be pain free for longer intervals then when local anesthesia is used alone. The objective of this study is to evaluate if patients receiving triamcinolone acetonide combined with local anesthesia and antibiotic compared to those receiving local anesthesia and antibiotic alone do better with postoperative pain control.

All eligible patients undergoing vitreoretinal surgery at the Emory Eye Center and Emory University Hospital will be offered enrollment. About 60 patients will be invited to participate in this study. Patients will undergo standard of care surgery. At the conclusion of surgery, patients will receive a retrobulbar antibiotic and anesthetic as standard of care. Half of the patients will receive this mixture plus steroid and the other half will receive this mixture plus saline. On postoperative day 1, patients will be given a questionnaire to assess pain. Pain levels in the two groups will be compared.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing vitreoretinal surgery at the Emory Eye Center Ambulatory Surgery Center and Emory University Hospital by retina attending faculty surgeons

排除标准

  • Unable to verbalize level of pain control
  • Pediatric patients (<18 years old)
  • Glaucoma, ocular hypertension, or glaucoma suspects
  • Allergy to local anesthetic
  • Pre-existing chronic pain requiring narcotic pain medication
  • Drug addiction
  • Impaired periorbital sensation (history of herpes simplex, zoster, corneal graft)

研究组 & 干预措施

Bupivicaine & Triamcinolone

Experimental

Retrobulbar anesthesia with Bupivicaine Hydrochloride and Triamcinolone Acetonide

干预措施: Triamcinolone (Drug)

Bupivicaine & Triamcinolone

Experimental

Retrobulbar anesthesia with Bupivicaine Hydrochloride and Triamcinolone Acetonide

干预措施: Bupivicaine Hydrochloride (Drug)

Bupivicaine

Active Comparator

Retrobulbar anesthesia with Bupivicaine Hydrochloride

干预措施: Bupivicaine Hydrochloride (Drug)

结局指标

主要结局

Mean Pain Score

时间窗: Post-Operative Day 1 (Up to 24 hours)

The mean pain score assessed by the Visual Analog Pain Scale ranging from 0-10; 10 being the worst possible pain.

次要结局

  • Mean Hydrocodone Intake(Post Surgery (Up to 24 hours))
  • Mean Acetaminophen Intake(Post Surgery (Up to 24 hours))
  • Mean Oxycodone Intake(Post Surgery (Up to 24 hours))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Timothy W. Olsen

Principal Investigator

Emory University

研究点 (1)

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