Duloxetine for Acute Post-mastectomy Pain: Placebo Controlled Dose Ranging Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- the first postoperative 24 h (patient controlled analgesia [PCA])morphine consumption
研究概览
简要总结
The objective of this study is to evaluate the analgesic effect of oral dulexitine tablet (administered 2 h before surgery) as well as the ideal dose for acute postmastectomy pain.
详细描述
patients undergoing mastectomy with axillary evacuation will be divided to four groups, Placebo group: received placebo capsule Duloxetine 30: received duloxetine 30 mg capsule Duloxetine 60: received duloxetine 60 mg capsule Duloxetine 90: received duloxetine 90 mg capsule the study medication is administered orall 2 h before surgery. Primary outcome variable: the first postoperative 24 h morphine consumption Secondary outcome: the VAS pain score measured every 4 h in the first 24 h postoperatively.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult females scheduled for unilateral MRM with axillary evacuation for breast cancer,
- •American Society of Anesthesiologists physical status (ASA) class I and II
排除标准
- •Patients with a known allergy to Duloxetine or morphine,
- •A history of drug or alcohol abuse,
- •Patients with impaired kidney or liver functions,
- •Patients with chronic pain or regularly receiving analgesics,
- •Any psychiatric illness that would interfere with the perception and the assessment of pain.
- •Any reason that resulted in the protocol violation.
研究组 & 干预措施
placebo group
干预措施: Duloxetine (Drug)
duloxetine 30
干预措施: Duloxetine (Drug)
duloxetine 60
干预措施: Duloxetine (Drug)
duloxetine 90
干预措施: Duloxetine (Drug)
结局指标
主要结局
the first postoperative 24 h (patient controlled analgesia [PCA])morphine consumption
时间窗: the first postoperative 24 hour
the cumulative patient controlled analgesia morphine consumption required by the patients to relieve their pain in the first postoperative 24 h
次要结局
- The level of consciousness assessed by "the Modified Ramsay Sedation score"(the score will be measured at 8 hour, 16 hour and 24 hour postoperatively)
- The occurrence of vomiting(The outcome will be obtained once 24 hour postoperatively)
- The intensity of pain measured by visual analogue pain scale (VAS)(The outcome will be assessed at 0 hour, 2 hour, 4 hour,8 hour, 16 hour and 24 hour postoperatively.)
- The quality of postoperative recovery, assessed by "The QoR-40 questionnaire" (the quality of recovery-40 questionnaire)(the questionnair will be assessed once, 24 hour postoperatively)
研究者
Diab Fuad Hetta
principle investigator
Assiut University