Status:
COMPLETED
Intravenous Remifentanil Patient-controlled Analgesia (PCA) and Epidural Patient Controlled Epidural Analgesia (PCEA) for Labor Analgesia
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Labor
Pain
Eligibility:
FEMALE
18-40 years
Phase:
PHASE4
Brief Summary
Women requesting analgesia do not always wish to receive a potent analgesic method, and may fear the risks of epidural analgesia. Study Aim: To determine whether remifentanil is effective for labor a...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Healthy women
- American Society of Anesthesiologists physical status class I or II
- Body weight less than 110 kg
- In active labor (including induced labor and premature rupture of membranes)
- Cervical dilatation at 2-6 cm
- Regular contractions
- Age between 18 and 40 years old
- Gestational age greater than 36 completed weeks
- Singleton pregnancy and vertex presentation
- Exclusion criteria:
- Contraindication for epidural analgesia (bleeding diathesis, neuropathy, severe scoliosis, previous spine surgery, local anesthetic allergy)
- Narcotic administration in the previous 2 hours
- Previous uterine surgery
- Pre-eclampsia and the inability to adequately understand the consent form
- Blocked nose, and any indication patient for whom epidural analgesia is medically indicated (cardiac disease, suspected difficult airway)
Exclusion
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00801047
Start Date
February 1 2010
End Date
July 1 2012
Last Update
April 21 2015
Active Locations (1)
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1
Hadassah Medical Organization
Jerusalem, Israel