Intravenous Remifentanil Patient-controlled Analgesia (PCA) and Epidural Patient Controlled Epidural Analgesia (PCEA) for Labor Analgesia
Comparison of the Efficacy Intravenous Remifentanil PCA and Epidural PCEA for Labor Analgesia
1 other identifier
interventional
50
1 country
1
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 analgesia when compared with standard treatment (epidural analgesia).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Feb 2010
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2008
CompletedFirst Posted
Study publicly available on registry
December 3, 2008
CompletedStudy Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedApril 21, 2015
February 1, 2010
2.4 years
December 2, 2008
April 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary analgesia end-point: VAS pain Score
1-6 hours
Study Arms (2)
1
EXPERIMENTALEpidural group
2
ACTIVE COMPARATORRemifentanil iv PCA
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hadassah Medical Organization
Jerusalem, Israel
Related Publications (1)
Hill D. Remifentanil patient-controlled analgesia should be routinely available for use in labour. Int J Obstet Anesth. 2008 Oct;17(4):336-9. doi: 10.1016/j.ijoa.2008.03.005. No abstract available.
PMID: 18617388BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carolyn F Weiniger, MB ChB
Hadassah HMO
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 2, 2008
First Posted
December 3, 2008
Study Start
February 1, 2010
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
April 21, 2015
Record last verified: 2010-02