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| Sponsored by: |
Northwestern University |
|---|---|
| Information provided by: | Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00418015 |
Purpose
Pharmocogenetics has allowed clinicians to identify associations between an individual's genetic profile and his/her response to drugs. The A118G (c.188A>G)is a single nucleotide polymorphism (SNP) of the mu-opioid receptor (OPRM1). The mutated protein, N40D, appears to increase the binding affinity and potency of beta-endorphin approximately 3-fold. Individuals carrying the variant receptor gene (A118G) may show differences in some of the functions mediated by beta-endorphin action at the altered OPRM1. Combined spinal-epidural (CSE) analgesia is a commonly utilized technique for labor analgesia. Analgesia is initiated with the intrathecal administration of a lipid-soluble opioid (e.g. fentanyl), sometimes combined with a local anesthetic. The mean (± SD) duration of analgesia after intrathecal fentanyl 25 microgram was 89 ± 43 min. The ED50 of intrathecal fentanyl for labor analgesia varies between 14 microgram to 18.2 microgram. The wide variability in the duration of analgesia, as was well the differences in ED50 may result from differences known to affect labor pain (e.g., ethnicity, parity, stage of labor). Another possible explanation for the differences in opioid requirements and duration, as well as incidence of side effects such as itching and nausea/vomiting, is that opioid responsiveness is determined by genetic variability of the µ-opioid receptor. The ED50 for intrathecal fentanyl labor analgesia was significantly lower for parturients carrying the A118G variant of the mu-opioid receptor, compared to parturients with the A118 wild type receptor. The purpose of this study is to determine whether polymorphism at nucleotide 118 of OPRM1 influences the duration of intrathecal opioid (fentanyl) labor analgesia, and intrathecal opioid (morphine) postoperative analgesia.
| Condition | Intervention |
|---|---|
|
Labour Post-Cesarean Delivery |
Procedure: Blood Draw |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Mu-Opioid Receptor Genetic Polymorphism and the Duration of Intrathecal Fentanyl Labor Analgesia. Mu-Opioid Receptor Genetic Polymorphism and the Efficacy of Postoperative Intrathecal Morphine Analgesia |
Blood Samples
| Enrollment: | 265 |
| Study Start Date: | October 2005 |
| Study Completion Date: | June 2007 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Pregnant women
Inclusion Criteria:Study1) Nulliparous women in spontaneous labor or with spontaneous rupture of membranes, term pregnancy (≥ 37 weeks gestation), vertex presentation, healthy, ASA PS 1-2, who plan neuraxial labor analgesia. Study 2) Nulliparous women undergoing elective primary Cesarean delivery (e.g., for breech presentation, macrosomia), term pregnancy (≥ 37 weeks gestation), healthy, ASA PS 1-2, planned spinal anesthesia.
Exclusion Criteria:1) Chronic or pregnancy induced disease, chronic opioid use, history of substance abuse, systemic opioid analgesia before initiation of neuraxial labor analgesia, cervical dilation < 2 cm or > 5 cm of time of request for neuraxial analgesia, allergy to fentanyl, Cesarean delivery. 2) Chronic or pregnancy induced disease, chronic opioid use, previous abdominal or pelvic surgery, allergy to fentanyl, morphine, or bupivacaine, BMI ≥ 40 kg/m2, history of substance abuse, failed spinal anesthesia, requirement for systemic opioid supplementation during Cesarean delivery.
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Contacts and Locations| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| Principal Investigator: | Cynthia A Wong, M.D. | Northwestern University |
More Information
| Responsible Party: | Northwestern University ( Cynthia A. Wong, M.D. ) |
| Study ID Numbers: | 0524-025 |
| Study First Received: | December 31, 2006 |
| Last Updated: | November 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00418015 History of Changes |
| Health Authority: | United States: Institutional Review Board |
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µ-opioid receptor neuraxial labor analgesia pharmacogenetics |
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Morphine Fentanyl Central Nervous System Depressants |
Peripheral Nervous System Agents Analgesics Analgesics, Opioid |
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Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Central Nervous System Depressants Peripheral Nervous System Agents |
Analgesics Central Nervous System Agents Pharmacologic Actions Analgesics, Opioid |