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临床试验/NCT04701593
NCT04701593已完成4 期

Using Intraoperative Triamcinolone Acetonide Irrigation to Reduce Post-Operative Pain From Scleral Buckle Surgery

Virginia Polytechnic Institute and State University1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2020年1月3日最近更新:
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
14
试验地点
1
主要终点
Post Operative Pain Day 1

研究概览

简要总结

PURPOSE: Scleral buckle surgery is a widely used ophthalmic surgery for the correction of rhegmatogenous retinal detachment. Studies suggest that eye pain is a common and underestimated occurrence after scleral buckle surgery, but as of yet, there is no definitive management method for reducing pain following scleral buckle surgery. The investigators aim to control pain following scleral buckle surgery with sub-tenon's irrigation with triamcinolone acetonide at the time of surgery. Using a randomized prospective clinical study, the investigators test if this technique will reduce the pain, nausea/vomiting, and analgesic use caused by scleral buckle surgery.

METHODS: Forty-eight patients undergoing scleral buckle surgery will be randomized into two groups. The experimental group receives a sub-tenon irrigation of 1 cc 40mg/mL triamcinolone acetonide around the base of the scleral buckle (0.25 cc in each quadrant) at time of operation. The control group does not receive any triamcinolone irrigation. Pain scores are measured 1 day post-operatively via 11-pt numerical rating scale as the primary outcome. The nausea/vomiting score is measured 1 day post-operatively via standard 6-pt scale. Patients track pain medication use via pill count. Values will be measured again at 1-2-week and 6 months post-op.

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
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Patient must have rhegmatogenous retinal detachment and be scheduled to undergo scleral buckle surgery for correction

排除标准

  • Advanced Glaucoma
  • History of corticosteroid responsive elevation in IOP
  • Allergy to Triamcinolone Acetonide or other corticosteroids
  • Pre-existing chronic pain disorders
  • Herpes zoster
  • Prior corneal allograft
  • Allergy to local anesthetic or penicillin
  • Patients unable to consent on own behalf
  • Patients unable to communicate pain and nausea levels
  • Pregnancy
  • Incarceration

研究组 & 干预措施

Experimental (Triamcinolone Acetonide)

Experimental

receives a sub-tenon irrigation of 1 cc 40mg/mL triamcinolone acetonide around the base of the scleral buckle (0.25 cc in each quadrant) at time of operation

干预措施: Triamcinolone Acetonide 40mg/mL (Drug)

结局指标

主要结局

Post Operative Pain Day 1

时间窗: 1 Day Post-Op

11-point Numerical Rating Scale (0-10, 10 being highest level of pain)

次要结局

  • Pain Medication Use (Tylenol in mg)(Cumulative amount used was assessed at one week after operation)
  • Post Operative Pain Week 1(1 Week Post-Op)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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