Labor Pain Clinical Trial
Official title:
The Optimal Dosage of Intrathecal Morphine for Peripartum Analgesia
The purpose of this study is to determine the ideal dosage of intrathecal morphine for intra and post partum analgesia, while minimizing the side effect profile.
Status | Terminated |
Enrollment | 89 |
Est. completion date | January 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - singleton pregnancy, - at least 36 weeks gestational age, - active labor (= 5 cm dilation) requesting neuraxial analgesia, - ASA I or II, - not currently taking pain medications. Exclusion Criteria: - multiple gestation, - preterm labor, - systemic opioids in the past 4 hours, - chronic pain syndromes, - chronic opioid use, - contraindications to regional anesthesia, - allergies to opioids, - significant co existing medical problems, - severe pregnancy induced hypertension, - sedatives, - magnesium therapy, - diabetes type 1. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Beth Israel Deaconess Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of Breakthrough pain | Rate of breakthrough pain is the number of episodes of breakthrough pain divided by the time period of labor. Time measured from placement of the neuraxial anesthetic, until delivery of the neonate. Because duration of labor is different for all patients, the rate is used as the primary outcome. | Average time to delivery | No |
Secondary | Postpartum pain | 24 hours | No |
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