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临床试验/NCT01146457
NCT01146457终止不适用

The Optimal Dosage of Intrathecal Morphine for Peripartum Analgesia

Beth Israel Deaconess Medical Center1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2010年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
83
试验地点
1
主要终点
Rate of Breakthrough Pain

研究概览

简要总结

The purpose of this study is to determine the ideal dosage of intrathecal morphine for intra and post partum analgesia, while minimizing the side effect profile.

详细描述

Regional anesthesia techniques such as combined spinal epidural (CSE) analgesia are very effective for the management of intrapartum pain. The advantages of these techniques are that they are safe when properly conducted and that they provide excellent analgesia while allowing the patient to remain awake and participate in the labor and delivery. The risks of maternal aspiration and fetal drug depression associated with general anesthesia are minimized. Finally, the effective analgesia associated with regional techniques blunt the hemodynamic effects caused by painful contractions and reduce maternal catecholamines, resulting in increased placental perfusion.1

Opioids in combination with local anesthetics in the spinal space provide effective pain relief during labor with minimal side effects. The advantages of spinal opioid administration include lack of motor blockade and faster onset of analgesia.2 In addition, since the opiate receptors are in the spinal space, a smaller amount of opioid can be used to provide excellent pain relief while minimizing the side effects. At Beth Israel Deaconess Medical Center (BIDMC), the obstetric anesthesiology group uses a standard spinal dosing for CSE during labor which includes: 1 ml of 0.25% bupivicaine with 12.5 mcg of fentanyl.

Yeh and colleagues have found that morphine 150 mcg added to the fentanyl-bupivicaine spinal injection can prolong the duration of spinal analgesia but was associated with increased side effects. 3 The side effect profile of spinal narcotics include: nausea, vomiting, pruritus, and urinary retention. Although these side effects for the most part can be easily treated, they can be bothersome to the post partum patient. In a previous study performed from our institution, the addition of 100 mcg of morphine to spinal bupivicaine and fentanyl reduced the rate of breakthrough pain during labor analgesia and prolonged the time to first request for supplementation. Overall, it was found that the incidence of side effects was low but the group that received the spinal morphine did have more nausea and vomiting compared with the placebo group. 4

In this current investigation, we would like to assess whether an even smaller dose of spinal morphine would provide an effective, pain free recovery from vaginal delivery while decreasing the incidence of side effects, specifically nausea and vomiting. We would like to perform a formal dose response study to identify the ideal dose of intrathecal morphine that would not compromise the pain relief during labor while minimizing the side effects.

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 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • singleton pregnancy,
  • at least 36 weeks gestational age,
  • active labor (≤ 5 cm dilation) requesting neuraxial analgesia,
  • ASA I or II,
  • not currently taking pain medications.

排除标准

  • multiple gestation,
  • preterm labor,
  • systemic opioids in the past 4 hours,
  • chronic pain syndromes,
  • chronic opioid use,
  • contraindications to regional anesthesia,
  • allergies to opioids,
  • significant co existing medical problems,
  • severe pregnancy induced hypertension,
  • sedatives,
  • magnesium therapy,
  • diabetes type 1.

研究组 & 干预措施

Placebo

Placebo Comparator

干预措施: Saline (Drug)

Morphine 25

Active Comparator

干预措施: Morphine (Drug)

Morphine 50

Active Comparator

干预措施: Morphine (Drug)

Morphine 75

Active Comparator

干预措施: Morphine (Drug)

Morphine 100

Active Comparator

干预措施: Morphine (Drug)

结局指标

主要结局

Rate of Breakthrough Pain

时间窗: Participants were followed for the duration of delivery, an average of 7 hours

Rate of breakthrough pain is the number of episodes of breakthrough pain divided by the number of hours of labor. Time measured from placement of the neuraxial anesthetic, until delivery of the neonate. Because duration of labor is different for all patients, the rate of breakthrough pain per hour is used as the primary outcome.

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

Phillip Hess

Chief of Obstetric Anesthesia

Beth Israel Deaconess Medical Center

研究点 (1)

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