NCT01466101撤回不适用
Analgesic Effect of Pregabalin in Patients Undergoing Total Abdominal Hysterectomy
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- total hydromorphone consumption
研究概览
简要总结
Pregabalin will decrease the total amount of opioid required in patients undergoing total abdominal hysterectomy. In addition, pregabalin will decrease the incidence of opioid-related side effects in patients undergoing total abdominal hysterectomy.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA Physical Status 1-2
- •Age 18-64
- •BMI 18-35
- •Scheduled for elective total abdominal hysterectomy (with or without bilateral salpingo-oophorectomy)
- •Gender: Female
- •Consent: Obtained
排除标准
- •Patient refusal
- •Allergy to study medication(s)
- •Preoperative use of gabapentinoids
- •Preoperative use of anticonvulsants
- •Daily use of analgesics
- •Hepatic disease
- •Renal insufficiency (Cr >2.0)
- •Alcohol or drug abuse
- •Pregnancy
- •Language: Non-English speaking
- •Patient expected to remain intubated after procedure
- •Patient request
- •Surgeon request
- •Allergic reaction to pregabalin
- •Surgical procedure significantly altered from scheduled procedure
研究组 & 干预措施
Pregabalin administration
Active Comparator
Administration of pregabalin
干预措施: Pregabalin administration (Drug)
Placebo
Placebo Comparator
Administration of placebo
干预措施: Placebo administration (Drug)
结局指标
主要结局
total hydromorphone consumption
时间窗: 24 hours
total hydromorphone consumption 24 hours post operatively
次要结局
- Pain Scores postoperative(Post operative period)
研究者
Christian Altman
Principal Investigator
Northwestern University
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