Effect of Oral Pregabalin on Hyperalgesia and Post-operative Pain in Patients Undergoing Nephrectomy Surgery: Sex Differential Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Mechanical threshold
研究概览
简要总结
Hyperalgesia is known to be caused by the excitatory amino acid through NMDA receptor. GABA, an inhibitory amino acid, alters the opioid receptor sensitivity against pain resulting hyperalgesia. If the GABA level can be maintained at certain level, the progression into hyperalgesia can be averted. GABA related drugs are known to decrease the postoperative opioid consumption, lower the degree of pain, and prevent hyperalgesia. We hypothesize the effective postoperative pain management and the prevention of hyperalgesia from pregabalin, GABA analogue, and the possible sex difference in such effects of pregabalin.
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
- 19 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18, <51 years
- •healthy patients accepted for video-assisted living donor nephrectomy
排除标准
- •Female patients who are pregnant or menopause
- •Patients undergoing hormonal therapy
- •Patients having neurologic disease or already taking GABA related drugs (pregabalin, gabapentin), or taking opioid drugs
- •Insulin resistant diabetes
- •Renal deficiency (eGFR < 60 ml/min/1.73 m2)
- •Emergency operation, hemodynamically unstable patients
- •Foreigner
- •allergic to medication given in this study
研究组 & 干预措施
Pregabalin_male
干预措施: Pregabalin_male (Drug)
Pregabalin_female
干预措施: Pregabalin_female (Drug)
Placebo_male
干预措施: Placebo_Men (Drug)
Placebo_female
干预措施: Placebo_Women (Drug)
结局指标
主要结局
Mechanical threshold
时间窗: from 1 day before op to postop 48 hr
Mechanical threshold can be measured using von Frey filaments at both incision site and non-dominant arm
次要结局
未报告次要终点