跳至主要内容
临床试验/NCT01982838
NCT01982838终止不适用

A Randomized Trial of the Impact of Three Labor Analgesia Techniques on Labor Duration in Spontaneously Laboring Nulliparous Parturients

Northwestern University1 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2010年7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
终止
入组人数
129
试验地点
1
主要终点
Duration of first stage of labor

研究概览

简要总结

The purpose of this study is to determine if there is a difference in the duration of the first stage of labor in nulliparous women in spontaneous labor with whom analgesia is maintained with a combined spinal epidural (CSE) technique versus nulliparous women in spontaneous labor with whom an epidural de novo technique is utilized. The investigators hypothesize that the duration of the first stage of labor will be no different in nulliparous patients who receive either intrathecal fentanyl or intrathecal fentanyl and bupivacaine, as part of a CSE technique. However, the duration of the first stage of labor will be shorter in parturients who receive intrathecal analgesia (as part of a CSE technique) compared to those who receive an epidural de novo technique with fentanyl and bupivacaine.

详细描述

At the first request for neuraxial labor analgesia, the cervix will be examined. If < 4.0 cm, the patient will be randomized to either Combined spinal epidural (CSE) technique with intrathecal fentanyl, CSE technique with intrathecal bupivacaine and fentanyl, or epidural de novo technique.

Labor analgesia will be administered in the sitting position, at either the L2-3 or L3-4 interspace. All patients will receive a 500mL intravenous bolus of Lactated Ringer's solution. The epidural space will be located using the loss-of-resistance technique utilizing a 17-G Tuohy epidural needle. Patients assigned to an intrathecal dose will utilize the standard needle-through-needle technique. A 19-G epidural catheter will be inserted 5 cm in the epidural space and maintenance epidural analgesia will be initiated. Patients assigned to an epidural de novo technique will have the epidural space identified with a similar loss-of-resistance technique. The epidural catheter will be inserted 5 cm into the epidural space. Epidural analgesia will be initiated with fentanyl 100mcg + bupivacaine 0.125% 10-20 mL (in divided doses). Maintenance epidural analgesia will then be initiated.

Maintenance epidural analgesia will consist of patient-controlled epidural analgesia (PCEA) with bupivacaine 0.0625% and fentanyl 1.95 mcg/mL at the following parameters: basal rate of 8 mL/hr with bolus dose = 8 mL, lock-out interval = 10 min and maximum volume = 32 mL/hr.

Breakthrough pain in all groups will be managed using anesthesiologist administered epidural boluses of bupivacaine 1.25 mg/mL, 10-15mL, without fentanyl. If instrumental vaginal delivery is required, patients will receive anesthesiologist administered epidural boluses of chloroprocaine 30 mg/mL, 5-10 mL. If a patient does not have an adequate level of analgesia or has a one-sided block, despite epidural redoses, the epidural catheter will be replaced at another level and 0.125% bupivacaine 5-15 mL will be administered until an adequate level of analgesia is established.

Because the primary outcome of the study is duration of first stage of labor, regular cervical examinations are necessary. Typically, full cervical dilation is diagnosed with a cervical examination only when the patient complains of rectal pressure, which is likely to be at a later time period in women with effective neuraxial analgesia compared to women with systemic opioid analgesia. Therefore, the duration of the first stage of labor will be artificially prolonged if regular cervical exams are not performed. The investigators intend to perform sterile cervical examinations at the first request for labor analgesia, then at routine times during the course of labor per the managing OB provider's discretion, and then every 2 hours after the patient reaches 90-100% cervical effacement until complete cervical dilation.

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
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Nulliparous,
  • •American Society of Anesthesia Physical Status (ASA) 2 females
  • •>18 years-old
  • •term (>37 weeks gestation)
  • •singleton
  • •vertex pregnancies
  • •spontaneous labor or spontaneous rupture of membranes

排除标准

  • •Non-vertex presentation
  • •induction of labor
  • •contraindication to opioid or neuraxial analgesia
  • •contraindication to combine spinal-epidural technique (e.g. unfavorable airway exam)
  • •cervical dilation > 4.0 cm
  • •administration of systemic hydromorphone within 4 hours of epidural request

研究组 & 干预措施

Group E

Active Comparator

Epidural de novo technique

干预措施: Epidural de novo (Procedure)

Group BF

Active Comparator

Combined spinal epidural (CSE) technique with intrathecal 0.5% Bupivicaine 2.5mg + Fentanyl 15mcg

干预措施: CSE (Procedure)

Group F

Active Comparator

Combined spinal epidural (CSE) technique with intrathecal fentanyl 25mcg

干预措施: CSE (Procedure)

结局指标

主要结局

Duration of first stage of labor

时间窗: Onset of contractions or spontaneous rupture of membrances to cervical dilation of 10cm

Sterile cervical examinations at the first request for labor analgesia will be done, then at routine times during the course of labor per the managing OB provider's discretion. When the patient reaches 90-100% cervical effacement, cervical exams will be done every two hours thereafter until the patient reaches complete cervical dilation. Cervical examinations will be performed using a sterile glove, by each patient's labor and delivery nurse or physician.

次要结局

  • Presence or absence of fetal heart rate decelerations(time of first analgesic dose - 60 minutes)

研究者

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

Christopher Cambic

Assistant Professor in Anesthesiology

Northwestern University

研究点 (1)

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