Safety and Efficacy of Peribulbar Anesthesia for Pain Management in Patients With Proliferative Diabetic Retinopathy During Panretinal Photocoagulation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
The purpose of this study was to compare two different anesthesia methods for pain control during panretinal photocoagulation (PRP), a type of laser surgery that treats proliferative diabetic retinopathy (PDR).
The study included eyes from patients with diabetes and proliferative diabetic retinopathy who were scheduled to undergo their first PRP session. Participants were split into two groups to receive either peribulbar anesthesia, which is a type of anesthesia injected through the eyelid, or a sham injection with topical anesthesia only.
Pain on a numerical scale and vital signs were recorded before and for 15 minutes during PRP. These results were compared between the two groups to determine which method delivers superior pain control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Adults aged 18 years or older with proliferative diabetic retinopathy
- •Scheduled to undergo their first PRP session
- •Able to maintain the required posture at the slit lamp throughout the procedure
排除标准
- •History of phobic anxiety disorder related to needles or injections
- •Known allergies or hypersensitivity to lidocaine, bupivacaine, or tetracaine
- •Use of analgesics within 24 hours prior to treatment
- •Cognitive or motor impairments that could hinder effective communication of pain.
研究组 & 干预措施
Peribulbar anesthesia intervention group
The intervention administered was topical anesthesia with peribulbar anesthesia consisting of a lidocaine and bupivacaine injection.
干预措施: Tetracaine 5% drops (Drug)
Peribulbar anesthesia intervention group
The intervention administered was topical anesthesia with peribulbar anesthesia consisting of a lidocaine and bupivacaine injection.
干预措施: Peribulbar anesthesia with 0.5% bupivacaine and 2% lidocaine (Drug)
Control group
The control group received only topical anesthesia and a sham peribulbar injection.
干预措施: Tetracaine 5% drops (Drug)