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Epidural Analgesia Versus IV Meperidine for Labor Pain Control

This study has been completed.

Sponsored by: Rambam Health Care Campus
Information provided by: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT00296751
  Purpose

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 Intervention
Labor Pain
Procedure: ECG recording
Procedure: Epidural catheter insertion
Drug: Intravenous meperidine injection
Drug: Epidural Bupivacaine and fentanyl injection

ChemIDplus related topics:   Fentanyl Citrate    Fentanyl    Bupivacaine    Bupivacaine hydrochloride    Meperidine    Meperidine hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Other, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:   Epidural Analgesia Versus IV Meperidine for Labor Pain Control. Objective Evaluation of the Pain Intensity Influence on the Autonomic Nervous System.

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Three lead ECG monitoring for 10 minutes will be performed 30 minutes after the administration.

Estimated Enrollment:   60
Study Start Date:   March 2006
Study Completion Date:   December 2006
Primary Completion Date:   December 2006 (Final data collection date for primary outcome measure)

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.
  Eligibility
Ages Eligible for Study:   20 Years to 40 Years
Genders 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.

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  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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


Study ID Numbers:   epiduralCTIL
First Received:   February 24, 2006
Last Updated:   April 18, 2008
ClinicalTrials.gov Identifier:   NCT00296751
Health Authority:   Israel: Israeli Health Ministry Pharmaceutical Administration

Study placed in the following topic categories:
Signs and Symptoms
Fentanyl
Labor Pain
Neurologic Manifestations
Bupivacaine
Pain
Meperidine

Additional relevant MeSH terms:
Nervous System Diseases
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Narcotics
Anesthetics, Local
Pharmacologic Actions
Adjuvants, Anesthesia
Sensory System Agents
Therapeutic Uses
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on October 10, 2008




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