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Epidural Analgesia Versus IV Meperidine for Labor Pain Control

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ClinicalTrials.gov Identifier: NCT00296751
Recruitment Status : Completed
First Posted : February 27, 2006
Last Update Posted : July 1, 2010
Sponsor:
Information provided by:
Rambam Health Care Campus

Study Description
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Brief Summary:
60 female that care for pain control during second stage of delivery, will choose between epidural or systemic analgesia. Continuous ECG (3 lead)monitoring will be recorded during the second stage for 10 minutes. 30 minutes after administration of either pain relief, a second recording of maternal ECG will take place for 10 minutes.

Condition or disease Intervention/treatment Phase
Labor Pain Procedure: ECG recording Procedure: Epidural catheter insertion Drug: Intravenous meperidine injection Drug: Epidural Bupivacaine and fentanyl injection Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Epidural Analgesia Versus IV Meperidine for Labor Pain Control. Objective Evaluation of the Pain Intensity Influence on the Autonomic Nervous System.
Study Start Date : March 2006
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Three lead ECG monitoring for 10 minutes will be performed 30 minutes after the administration.

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00296751


Locations
Israel
Rambam - health care campus
Haifa, Israel, 31096
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Study Director: Amir Weissman, MD Rambam Health Care Campus
Principal Investigator: Olga Torchov, MD Rambam Health Care Campus
More Information
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ClinicalTrials.gov Identifier: NCT00296751     History of Changes
Other Study ID Numbers: epiduralCTIL
First Posted: February 27, 2006    Key Record Dates
Last Update Posted: July 1, 2010
Last Verified: April 2008

Additional relevant MeSH terms:
Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Bupivacaine
Fentanyl
Meperidine
Anesthetics, Local
Anesthetics
 Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General