NCT00803725已完成不适用
Spinal Mepivicaine With Fentanyl for Outpatient Knee Arthroscopy Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Time to complete motor block regression (0) as measured by modified Bromage scale.
研究概览
简要总结
The purpose of this study is to determine if the addition of intrathecal fentanyl to low dose mepivacaine spinal anesthesia provides adequate surgical anesthesia with shorter duration of motor blockade.
It is hypothesized that lower doses of spinal mepivacaine when combined with fentanyl will result in adequate surgical block for knee arthroscopy surgery with faster recovery and discharge compared to mepivacaine alone.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients having unilateral arthroscopic surgery of the knee;
- •ASA I-III status;
- •Age 18-80 years;
排除标准
- •Patients who have previous history of hypersensitivity to local anesthetics or contraindications for spinal anesthesia (i.e. bleeding diathesis, coagulopathy);
- •Patients with radiating low back pain and neurological deficits in lower extremities;
- •Patients who are incapable of giving an informed consent.
研究组 & 干预措施
1
Active Comparator
Mepivicaine for spinal anesthesia
干预措施: Mepivacaine without fentanyl (Drug)
2
Experimental
Mepivacaine with Fentanyl for spinal anesthesia
干预措施: Mepivacaine with Fentanyl (Drug)
结局指标
主要结局
Time to complete motor block regression (0) as measured by modified Bromage scale.
时间窗: Every 2 minutes from administration of the spinal until complete onset.
次要结局
- Block success, peak, and duration; time to ambulation, urination, discharge; incidence of adverse events.(Up to 72 hours after surgery.)
研究者
研究点 (1)
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