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临床试验/NCT02619409
NCT02619409已完成不适用

Evaluation of the Duration of Bupivacaine Spinal Block as the Primary Anesthetic for Orthopedic Procedures With and Without Epinephrine Wash

Medical University of South Carolina1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年2月11日最近更新:
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
30
试验地点
1
主要终点
Duration of Sensory Block

研究概览

简要总结

Bupivacaine spinal is commonly performed as the primary anesthetic for orthopedic procedures. In some cases the duration of the block is inadequate. An epinephrine wash is sometimes performed to prolong the duration of the block. The epinephrine wash may prolong the duration of the block, and if it does, to what extent?

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age or older
  • Patients scheduled for total hip or knee replacement

排除标准

  • Patients taking anticoagulation
  • Infection at or near the intended needle insertion site
  • Patients with sacral decubitus ulcer at or near the intended needle insertion site aortic stenosis
  • Complex spine anatomy
  • ASA class greater than III
  • Failed SAB as determined by the staff anesthesiologist

研究组 & 干预措施

EPI75 group

Active Comparator

The EPI75 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.075 cc, and sterile saline 0.025%.

干预措施: EPI75 group (Drug)

Bupivacaine Only

Placebo Comparator

The bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc.

干预措施: Bupivacaine Only (Drug)

EPI25 group

Active Comparator

The EPI25 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.025cc, and sterile saline 0.075cc.

干预措施: EPI25 (Drug)

EPI50 group

Active Comparator

The EPI50 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.05cc, and sterile saline 0.05cc.

干预措施: EPI50 group (Drug)

EPI100 group

Active Comparator

The EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc

干预措施: EPI100 group (Drug)

结局指标

主要结局

Duration of Sensory Block

时间窗: 12 hours

Duration of the sensory block at the T12 dermatome will be assessed in the post operative phase

Duration of Motor Block

时间窗: 12 hours

(hip felxion) of the non operative leg

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eric Bolin

Assistant Professor

Medical University of South Carolina

研究点 (1)

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