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临床试验/NCT02159807
NCT02159807已完成不适用

Randomized Double-blinded Study Designed to Optimize the Dose of Bupivacaine in Combined Spinal Epidurals to Reduce the Incidence of Fetal Bradycardia and Maternal Hypotension

St. Luke's-Roosevelt Hospital Center1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2015年4月24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
170
试验地点
1
主要终点
Maternal Blood Pressure

研究概览

简要总结

The purpose of this study is to determine what dose of medication administered through a combined spinal epidural (CSE) provides the optimal pain relief with the minimal amount of side effects. The 3 doses studied here (1.25, 1.66 and 2.5mg) are routinely use on the labor floor (depending on the physician preference) but the idea is to quantify safety, efficacy and side effects for each of these doses.

详细描述

A combined spinal epidural (CSE), which is the investigators' customary method of providing pain relief during your labor, is the identification of the epidural space in your lower back with a needle, followed by passing a thinner and longer needle through the first needle. This second needle will enter the patient's "spinal" (intrathecal) space by passing through the dura (thin covering separating the epidural space from the spinal space). The spinal (intrathecal) space is identified by flow of spinal fluid. The dura is the envelope around the spinal cord and the intrathecal space which is filled with spinal fluid. Medication will be injected at once into the spinal space, the thinner needle removed and a fine tube (catheter) will be threaded through the first needle into the epidural space. This catheter is in the epidural space and medication can be given through this catheter later on (hence the term combined) if needed. This study is a comparison of three different dosages (1.25mg, 1.66mg and 2.5 mg) of the local anesthetic (Bupivacaine) that we frequently use in the spinal, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), and of its effects on the patient's blood pressure (risk of maternal's drop of the blood pressure with possible bad effects on the blood flow to the baby), on the patient's baby's heart rate (risk of slowing down of the baby heart rate as a consequence of decreased blood flow to the baby), and the patient's pain relief (higher dose of medications are usually more effective for maternal pain relief but have side effects that can be bad for the mother and the baby). The doses of Bupivacaine the investigator routinely use on the labor and delivery floor go from 1.25 to 2.5 mg depending on clinician preferences. These doses are considered standard of care in the literature.

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, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 48 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • ASA (American Society of Anesthesiologists Physical status) 1-2 parturients at term requesting labor analgesia
  • between 37 and 42 weeks gestational age
  • maternal age of 18 years or greater

排除标准

  • Parturients with pre-eclampsia
  • History of pregnancy induced hypertension
  • Patients in whom a spinal anesthetic is contraindicated (e.g. coagulopathy, local infection) or those in whom a CSE cannot be performed
  • Patients with non reassuring fetal heart rate tracings prior to placement of the CSE

研究组 & 干预措施

1.25 mg Bupivacaine

Active Comparator

1.25mg of bupivacaine dose with 20 mcg of fentanyl was injected in the spinal portion of the anesthetic

干预措施: Bupivacaine (Drug)

1.25 mg Bupivacaine

Active Comparator

1.25mg of bupivacaine dose with 20 mcg of fentanyl was injected in the spinal portion of the anesthetic

干预措施: Fentanyl (Drug)

1.66 mg Bupivacaine

Active Comparator

1.66mg of bupivacaine dose with 20 mcg of fentanyl was injected in the spinal portion of the anesthetic

干预措施: Bupivacaine (Drug)

1.66 mg Bupivacaine

Active Comparator

1.66mg of bupivacaine dose with 20 mcg of fentanyl was injected in the spinal portion of the anesthetic

干预措施: Fentanyl (Drug)

2.5 mg Bupivacaine

Active Comparator

2.5mg of bupivacaine dose with 20 mcg of fentanyl was injected in the spinal portion of the anesthetic

干预措施: Bupivacaine (Drug)

2.5 mg Bupivacaine

Active Comparator

2.5mg of bupivacaine dose with 20 mcg of fentanyl was injected in the spinal portion of the anesthetic

干预措施: Fentanyl (Drug)

结局指标

主要结局

Maternal Blood Pressure

时间窗: at 1 hour

Maternal diastolic blood pressure at 60 minutes after epidural to measure maternal hypotension

次要结局

  • Mean Change in Visual Analog Scale for Pain(baseline and 60 minutes)
  • Fetal Heart Rate at 1 Hour(at 1 hour)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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