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临床试验/NCT01701102
NCT01701102已完成不适用

Optimal Dose of Spinal Mepivacaine Combined With Fentanyl For Knee Arthroscopy

Hospital for Special Surgery, New York1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2011年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
56
试验地点
1
主要终点
Time From Spinal Administration to Block Regression to the S1 Dermatome in Post-Anesthesia Care Unit (PACU)

研究概览

简要总结

Prolonged motor block and delayed ability to walk are limitations of spinal anesthesia in ambulatory (same-day) surgery. This can be improved by lowering the dose of local anesthetic (a medication that, when injected around nerves, blocks nerve conduction, resulting in numbness and weakness) used in the spine, but too low a dose can result in an incomplete block (inadequate anesthesia) in some patients. There is evidence that adding a low dose of fentanyl, a narcotic, to mepivacaine enhances the anesthetic effect. The purpose of this study is to determine the lowest dose of mepivacaine, a local anesthetic, when combined with fentanyl, for which spinal anesthesia is adequate for ambulatory knee arthroscopy.

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, Investigator)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Subjects aged 18-60
  • •Patients scheduled for "simple" knee arthroscopies, including meniscectomy, debridement, and plica.

排除标准

  • •Subjects aged <18 or >60
  • •Subjects greater than 190 cm in height
  • •Patients scheduled for ligament reconstruction or surgery involving bone
  • •Daily use of narcotics for greater than one week pre-op

研究组 & 干预措施

Mepivacaine 27 mg plus fentanyl 10 µg

Active Comparator

干预措施: Mepivacaine (27 mg) plus fentanyl (Procedure)

Mepivacaine 24 mg plus fentanyl 10 µg

Active Comparator

干预措施: Mepivacaine (24 mg) plus fentanyl (Procedure)

Mepivacaine 30 mg plus fentanyl 10 µg

Active Comparator

干预措施: Mepivacaine (30 mg) plus fentanyl (Procedure)

Mepivacaine 37.5 mg

Active Comparator

干预措施: Mepivacaine (Procedure)

结局指标

主要结局

Time From Spinal Administration to Block Regression to the S1 Dermatome in Post-Anesthesia Care Unit (PACU)

时间窗: Participants will be followed for the duration of their recovery after surgery in the post-anesthesia care unit (PACU), an expected average of 2-4 hours.

The time frame of the study for each patient only covers the period between time of surgery and time of discharge from the hospital, which is on the same day as the day of surgery

次要结局

未报告次要终点

研究者

发起方
Hospital for Special Surgery, New York
申办方类型
Other
责任方
Sponsor

研究点 (1)

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