"Preoperative Oral Duloxetine: Does it Affect Duration of Spinal Anesthesia and Early Postoperative Pain After Arthroscopic ACL Repair?" a Prospective, Randomized, Double-blind Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Assess the onset of spinal anesthesia
研究概览
简要总结
The purpose of the study is to use duloxetine as premedication in Anterior cruciate ligament repair under spinal anesthesia and evaluate the effect on onset and duration of spinal anesthesia and postoperative pain control.
详细描述
We designed this randomized, double-blind study to evaluate the effectiveness of administration of oral duloxetine 2 hours preoperatively on the onset and the duration of the spinal anesthesia in arthroscopic anterior cruciate ligament (ACL) repair and the role of duloxetine on postoperative analgesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists I or II.
- •Sex: Both sexes.
- •Age between 18 and
- •Height 155-180 cm.
- •Patients scheduled for arthroscopic anterior cruciate ligament (ACL) repair under spinal anesthesia.
排除标准
- •Declining to give written informed consent.
- •History of allergy to the medications used in the study.
- •Had a history of drug or alcohol abuse.
- •Taking opioids or sedative medications.
- •Inability to communicate with patients to evaluate the postoperative pain.
- •Need for postoperative ICU hospitalization.
- •Hepatic or renal failure.
- •Patients with a history of taking duloxetine or any SSRIs.
- •Contraindications to regional anesthesia (including coagulopathy and local infection).
- •Psychiatric disorders with antipsycotics or antidepressants (tricylic or MAOIs).
- •Antiplatelets (aspirin, clopidogrel) or anticoagulant (warfarin).
- •Quinolones (ciprofloxacin).
研究组 & 干预措施
Group D (duloxetine group)
Two hours before surgery, participants received oral duloxetine 60 mg tablets in the ward then transferred to OR to receive spinal anesthesia before surgery.
干预措施: Duloxetine 60mg (Drug)
Group C (control group)
Two hours before surgery, participants received oral placebo tablets in the ward then transferred to OR to receive spinal anesthesia before surgery.
干预措施: Placebo (Drug)
结局指标
主要结局
Assess the onset of spinal anesthesia
时间窗: 20 min
Time to T10 sensory block and time to Bromage 1 motor block
次要结局
- Duration of spinal anesthesia(4 hours)
- Postoperative pain(24 hours)
- Time for first postoperative rescue analgesia request, frequency, and total morphine consumption(24 hours)
研究者
Tamer Samir Abdelsalam
Lecturer of Anesthesia
Ain Shams University