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Completed

NCT Number: NCT02099877

μ-opioid Receptor Polymorphism and Opioid Analgesia

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

American University of Beirut

Beirut, Lebanon

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Fentanyl

Drug

Epidural analgesia will be initiated with 100µg of epidural fentanyl

Primary outcomes

  1. Duration of epidural fentanyl

    Time frame: up to 24h

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

Secondary outcomes

  1. VAS at request for analgesia

    Time frame: up to 24h

  2. Cervical dilation at request for analgesia

    Time frame: up to 24h

  3. Incidence of pruritus, nausea, and vomiting.

    Time frame: up to 24h

Sponsors and collaborators

Lead sponsor

American University of Beirut Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Mar 31, 2014
Registry last updated
Feb 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.