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临床试验/NCT01182220
NCT01182220已完成不适用

Comparison of Ultrasound Guided L5/S1 Epidural Catheter Placement With Standard Epidural Catheter Placement: A Randomized Trial

University of Chicago1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
1.Blocking of S1 and S2 dermatomes

研究概览

简要总结

  1. labor epidural quite often require bolus supplementation for better pain control control. Quite often this is due to sparing of sacral nerves.
  2. If epidural is placed low in the L5/S1 interspace using ultrasound, this may minimize bolus requirement and improve patient labor experience.

详细描述

After consent patients will be randomized to one of the two groups: Control Group or the Experimental Group. Patients will be blinded to the group assignment.

In each subject prior to labor epidural placement, intravenous access will be obtained and if indicated fluid bolus will be given. There after heart and lung monitors will be placed. Procedure will be placed in sitting position. Standard epidural kit will be used.

In the Control Group the patient will be seated. Low back area will be prepped and draped in a sterile fashion. Lumbar interspaces will be identified clinically and epidural catheter will be inserted in the interspace deemed most appropriate. Epidural space will be accessed using loss of resistance to air technique. Once identified, a 20g open tip catheter will be placed can into the space.

In the Experimental Group, subjects back will be scanned with an Ultrasound probe. The interspace L5/S1, the lowest interspace in the spine will be identified and marked with the marker on the skin. Thereafter epidural catheter will be place using the exactly the same technique as used in the control group.

Once in place, catheter will be aspirated to rule out any intravascular placement. Thereafter a test dose composed of 45 mg lidocaine and 15 microgram epinephrine will be injected via the catheter to rule out any misplacement of catheter either in the intrathecal space or blood vessels. Once proper placement confirmed, catheter will be dose with 10 ml 0.25% bupivacaine in 5 ml boluses.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Active labor age 18 or older

排除标准

  • Known contraindications to epidural analgesia
  • Any neurologic illness
  • Fetal abnormalities

结局指标

主要结局

1.Blocking of S1 and S2 dermatomes

时间窗: 30 minutes after loading epidural

After test dose and loading up of catheter, s1 and s2 dermatome blockage will be tested in L5/S1 epidural group vs conventionally placed epidural group. Idea is see if higher incidence of S1 and S2 blockage can be demonstrated in low epidural group.

次要结局

  • Number of top up doses for pain control throughout labor(from insertion till delivery average 8-24 hrs)
  • Patient satisfaction(Evaluated on Post deliver day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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