Status:
COMPLETED
Mu-Opioid Receptor Genetic Polymorphism and Intrathecal Analgesia
Lead Sponsor:
Northwestern University
Conditions:
Labor Pain
Post-cesarean Delivery
Eligibility:
FEMALE
18-55 years
Brief Summary
Pharmacogenetics 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) o...
Detailed Description
Study 1 (intrathecal fentanyl): The primary outcome variable is duration of intrathecal fentanyl analgesia. A two-sided log rank test with an overall sample size of 152 subjects (wild type OPRM1 = 106...
Eligibility Criteria
Inclusion
- Study 1: Laboring Women
- Nulliparous women in spontaneous labor or with spontaneous rupture of membranes
- Term pregnancy (≥ 37 weeks gestation)
- Vertex presentation
- Healthy, ASA PS 1-2
- Desire neuraxial labor analgesia.
- Study 2: Cesarean Delivery
- Nulliparous women undergoing elective primary Cesarean delivery (e.g., for breech presentation, macrosomia)
- Term pregnancy (≥ 37 weeks gestation)
- Healthy, ASA PS 1-2
- Desired spinal anesthesia.
Exclusion
- Study 1: Laboring Women
- 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
- Study 2: Cesarean delivery
- 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.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
293 Patients enrolled
Trial Details
Trial ID
NCT00418015
Start Date
October 1 2005
End Date
June 1 2007
Last Update
April 14 2014
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611