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临床试验/NCT02099877
NCT02099877已完成不适用

Observational Study: The Effect of μ-opioid Receptor Genetic Polymorphism on Neuraxial Opioid Labor Analgesia

American University of Beirut Medical Center1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2013年10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
已完成
入组人数
250
试验地点
1
主要终点
Duration of epidural fentanyl

研究概览

简要总结

In this prospective observational double-blind study, the investigators aim to assess the effect of the single nucleotide polymorphism of the μ-opioid receptor gene (OPRM1, p.118A/G) on the duration of epidural fentanyl labor analgesia.

详细描述

The single nucleotide polymorphism (SNP), p.118A/G of the µ -opioid receptor gene (OPRM1), may alter pain perception and individual response to opioid analgesia. This SNP leads to a variant µ-opioid receptor in which an asparagine is substituted for aspartate as the 102nd amino acid of the receptor protein (p.Asn102Asp). At the investigators' institution, it is common practice to initiate labor analgesia with epidural fentanyl. No data are available to determine how the µ-opioid polymorphism affects pain perception and response to opioids, such as fentanyl, in the investigators' population. The investigators aim to assess the effect of the single nucleotide polymorphism of the µ-opioid receptor gene (OPRM1, p.118A/G) on duration of epidural fentanyl labor analgesia.

This is a prospective observational and double-blind study. Before initiation of epidural labor analgesia, venous blood will be drawn into coded EDTA tubes. DNA isolation and genotyping of OPRM1:p.118A/G will be performed at the American University of Beirut. In 250 parturients, labor epidural analgesia will be initiated with 100 µg of epidural fentanyl following a test dose of lidocaine and epinephrine. No drugs will be injected until second request of analgesia. Patients will be divided into two groups based on their genetic groups: Group A consists of wild-type homozygote (A118), and Group G includes heterozygote and homozygote carrying the G118 allele. Duration of fentanyl analgesia (primary outcome) will be compared. Data will be presented as a mean ± SD or numbers and percentages. Statistical analysis will be performed with the Student's t-test, Chi-square or Fisher's exact test as appropriate. P value <0.05 will be considered significant.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

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

入选标准

  • Nulliparous parturients ≥ 37 weeks gestation, with ASA I or II, with an uncomplicated course of singleton vertex pregnancy (in spontaneous labor or with spontaneous rupture of membrane), requesting epidural analgesia for pain relief

排除标准

  • Advanced cervical dilation (> 5 cm) at the time of request for epidural analgesia
  • Severe medical or obstetric complications (preeclampsia, uncontrolled pregestational diabetes, etc...)
  • Multiple gestation
  • Contraindication to epidural analgesia
  • Local anesthetics or fentanyl allergy
  • History of chronic opioid use or recent acute opioid use.

研究组 & 干预措施

Nulliparous requesting epidural

Nulliparous parturients ≥ 37 weeks gestation, with ASA I or II, with an uncomplicated course of singleton vertex pregnancy requesting epidural analgesia for pain relief will be included.

When the patient requests analgesia, cervical dilatation will be verified by the obstetric resident/attending. Then epidural analgesia will be initiated with a test dose of 3mL of 2% lidocaine and epinephrine 15 µg and a dose of fentanyl 100 µg diluted to a total volume of 10 mL with preservative- free normal saline. Before placement of the epidural, venous blood (2 mL) will be drawn into special tubes. Genotyping of OPRM1: p.118A/G will be also performed.

干预措施: Fentanyl (Drug)

结局指标

主要结局

Duration of epidural fentanyl

时间窗: up to 24h

The primary outcome variable is duration of epidural fentanyl for labor analgesia.

次要结局

  • VAS at request for analgesia(up to 24h)
  • Cervical dilation at request for analgesia(up to 24h)
  • Incidence of pruritus, nausea, and vomiting.(up to 24h)

研究者

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

Sahar Sayyid

Professor

American University of Beirut Medical Center

研究点 (1)

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