- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00296751
Epidural Analgesia Versus IV Meperidine for Labor Pain Control
Epidural Analgesia Versus IV Meperidine for Labor Pain Control. Objective Evaluation of the Pain Intensity Influence on the Autonomic Nervous System.
Study Overview
Status
Conditions
Detailed Description
Population 60 female during second stage of delivery
- Inclusion criteria : all parturients requiring pain relief will choose between systemic or epidural analgesia.
- Exclusion Criteria: all parturients with cardiac disease, neurological disease, endocrine disease, diabetes, hypertension or any parturients being treated with medications that might effect the cardiovascular autonomic system.
- Method: A 10 minute recording of a 3 lead ECG will be performed during the second stage of the delivery (3-7 CM opening).
the parturient will be lying on her left side for that period.
- 30 minutes after administration of either epidural or systemic Meperidine for pain relief, a second recording of maternal ECG will take place for 10 minutes.
- estimated duration of the procedure about one hour per woman.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Haifa, Israel, 31096
- Rambam - health care campus
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: all parturients requiring pain relief will choose between systemic or epidural analgesia.
Exclusion Criteria: all parturients with cardiac disease, neurological disease, endocrine disease, diabetes, hypertension or any parturients being treated with medications that might effect the cardiovascular or autonomic system.
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Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Three lead ECG monitoring for 10 minutes will be performed 30 minutes after the administration.
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Amir Weissman, MD, Rambam Health Care Campus
- Principal Investigator: Olga Torchov, MD, Rambam Health Care Campus
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Labor Pain
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Anesthetics, Local
- Fentanyl
- Bupivacaine
- Meperidine
Other Study ID Numbers
- epiduralCTIL
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