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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00418015 |
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Date of registration:
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31/12/2006 |
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Primary sponsor: |
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Public title:
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Mu-Opioid Receptor Genetic Polymorphism and Intrathecal Analgesia
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Scientific title:
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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 |
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Date of first enrolment:
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October 2005 |
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Target sample size:
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293 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00418015 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Cynthia A Wong, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Northwestern University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
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 Criteria:
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.
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Labor Pain
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Post-cesarean Delivery
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Intervention(s)
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Procedure: Blood Draw
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Primary Outcome(s)
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Duration of Intrathecal Analgesia Following Cesarean Delivery
[Time Frame: 0 to 72 hours following cesarean delivery]
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Duration of Intrathecal Fentanyl Analgesia
[Time Frame: Time (0-1440 minutes) to first analgesia request]
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Visual Analog Pain Scale (0 to 100) at Analgesia Request Following Intrathecal Intervention
[Time Frame: VAS at analgesia request]
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Secondary Outcome(s)
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Severity of Pruritus Following Fentanyl
[Time Frame: Labor analgesia]
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Subjects With Pruritus at 24 Hours Post Morphine
[Time Frame: 24 hours post cesarean delivery]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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