跳至主要内容
临床试验/NCT00691795
NCT00691795撤回4 期

Comparison of Fentanyl-bupivacaine and Clonidine-bupivacaine for Breakthrough Pain in Advanced Labor in Patients With Continuous Epidural Analgesia

Columbia University1 个研究点 分布在 1 个国家开始时间: 2008年6月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
试验地点
1
主要终点
Pain score on a VAS scale (success = score less than or equal to 2 on a 10 point scale)

研究概览

简要总结

Epidural analgesia is widely regarding as the most effective analgesic strategy for labor pain. Modern practice is to utilize dilute local anesthetics as a continuous infusion along with an opioid, e.g., our common "recipe" of 12 ml/hr of 0.0625% bupivacaine with 2 micrograms/ml fentanyl, after the initial dose to maintain patient comfort until delivery. This dose of the infusion often provides adequate comfort without interfering with the mobility of the patient and her ability to effectively push during delivery. However, this low dose epidural infusion strategy often results in recurrence of pain after an initial pain free period.

This breakthrough pain is treated by administering small boluses of analgesics via the epidural catheter. The pain occurring in labor is initially of visceral origin and is mediated by pain fibers originating from the low thoracic and upper lumbar segments of the spinal cord. As labor progresses to the late first phase (also known as transitional stage), pain sensations originating from the distension of the pelvic floor, vagina and perineum adds a somatic component to labor pain. This type of breakthrough pain is often difficult to treat.

Although requests from patients to alleviate late stage breakthrough pain are common, no one knows the most effective strategy for pain management in this stage of labor. This study is designed to compare the efficacy of two treatments for controlling late first stage breakthrough pain during labor with an epidural infusion in place: clonidine-bupivacaine versus fentanyl-bupivacaine.

Women who have labor epidural analgesia in place will be enrolled to be randomized if and when they present with breakthrough pain in the late first stage or second stage of labor (≥ 8 cm dilated). They will receive 8 ml of a solution containing 10 mg bupivacaine and 75 micrograms of either fentanyl (an opioid or "narcotic") or clonidine (an "alpha-2 agonist known to be effective as an epidural analgesic).

Pain relief, labor progress and outcome will be assessed to compare fentanyl versus clonidine.

It is the hypothesis of this study that clonidine added to bupivacaine is a better analgesic than fentanyl added to bupivacaine for breakthrough pain in advanced labor.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • women in labor at term pregnancy
  • epidural analgesia in place
  • breakthrough pain in advanced labor

排除标准

  • chronic pain syndrome
  • receiving systemic opioids within 4 hours
  • receiving chronic antidepressants, clonidine, opioids

研究组 & 干预措施

CLONIDINE

Experimental

Participants randomized to this arm of the study receive 75 micrograms clonidine with the bupivacaine in their epidural when requesting pain relief in advanced labor

干预措施: Clonidine or fentanyl (Drug)

FENTANYL

Experimental

Participants randomized to this arm of the study receive 75 micrograms fentanyl with the bupivacaine in their epidural when requesting pain relief in advanced labor

干预措施: Clonidine or fentanyl (Drug)

结局指标

主要结局

Pain score on a VAS scale (success = score less than or equal to 2 on a 10 point scale)

时间窗: 15 minutes

次要结局

  • Maternal blood pressure(2 hours)
  • Maternal heart rate(2 hour)
  • Neonatal Apgar score(1 and 5 minutes post delivery)
  • Mode of delivery (spontaneous vaginal versus instrumental vaginal versus cesarean(at delivery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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