The Effect of Pretreated Gabapentin on Hyeralgesia Occurring in the Second Operation in Staged Bilateral Cataract Surgery
试验速览
- 阶段
- 4 期
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- proportion of subjects who answer that "pain was greater" in the second eye surgery
研究概览
简要总结
Gabapentin pretreatment may reduce hyperalgesia occurring at the second surgery in serial, bilateral cataract surgery.
详细描述
Hyperalgesia occurring at the second operation in bilateral eye surgery is well known, and mechanism of central sensitization might be involved. Gabapentin is known to lower the effect of central sensitization, and its effect on acute postoperative pain has been reported. Therefore, pretreatment of gabapentin after first operation may reduce the pain at second operation.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient of ASA(American Cociety of Anesthesiology) class I, II, III between age 20 to 80, scheduled for serial bilateral cataract surgery(1 weel interval)
排除标准
- •refuse to participate
- •BMI<16 or BMI >30
- •severe cardiovascular, pulmonary, renal disease
- •alcohol or drug abuse
- •currently taking CNS(central nervous system) inhibitory drugs
- •taking antiacids
- •depressive disorder pregnancy
研究组 & 干预措施
Gabapentin
gabapentin pretreatment
干预措施: gabapentin (Drug)
Placebo
placebo drug pretreatment
干预措施: placebo (Drug)
结局指标
主要结局
proportion of subjects who answer that "pain was greater" in the second eye surgery
时间窗: Intra operative (pain while fluid injection to anterior chamber)
次要结局
- perioperative pain(end of surgery, post-op 1hr at PACU, at out-patient ward, post-op 1 day)
研究者
Hee-Pyoung Park
associate professor
Seoul National University Hospital