μ-opioid Receptor Polymorphism and Opioid Analgesia

Pharmacogenetic and Duration of Labor Fentanyl Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02099877
• Other study ID #: ANES.SS.11
• Status: Completed
• Phase: N/A
• First received: March 25, 2014
• Last updated: February 20, 2018
• Start date: October 2013
• Est. completion date: June 2017

Study information

• Verified date: February 2018
• Source: American University of Beirut Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pharmacogenetic and Duration of Labor Fentanyl Analgesia

Intervention

Drug:
• Fentanyl
Epidural analgesia will be initiated with 100µg of epidural fentanyl

Locations

Country	Name	City	State
Lebanon	American University of Beirut	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of epidural fentanyl	The primary outcome variable is duration of epidural fentanyl for labor analgesia.	up to 24h
Secondary	VAS at request for analgesia		up to 24h
Secondary	Cervical dilation at request for analgesia		up to 24h
Secondary	Incidence of pruritus, nausea, and vomiting.		up to 24h