μ-opioid Receptor Polymorphism and Opioid Analgesia

NCT02099877 | Completed

• 1 other identifier: ANES.SS.11
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pharmacogenetic and Duration of Labor Fentanyl Analgesia

Keywords

µ-opioid receptor polymorphism; Opioids; Opioid analgesia; Labor analgesia

Outcome Measures

Primary Outcomes (1)

• Duration of epidural fentanyl

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

  up to 24h

Secondary Outcomes (3)

• 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

Study Arms (1)

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.

Drug: Fentanyl

Interventions

Fentanyl DRUG

Epidural analgesia will be initiated with 100µg of epidural fentanyl

Nulliparous requesting epidural

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut

Beirut, Lebanon

Location

MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sahar Siddik Sayyid, MD

  American Univesity of Beirut

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 25, 2014
• First Posted: March 31, 2014
• Study Start: October 1, 2013
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: February 22, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)