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Epidural Analgesia Versus IV Meperidine for Labor Pain Control

This study has been completed.
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00296751
First received: February 24, 2006
Last updated: June 30, 2010
Last verified: April 2008
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

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

No publications provided

ClinicalTrials.gov Identifier: NCT00296751     History of Changes
Other Study ID Numbers: epiduralCTIL
Study First Received: February 24, 2006
Last Updated: June 30, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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
 Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Analgesics
Adjuvants, Anesthesia
Narcotics
Anesthetics, Intravenous
Anesthetics, General

ClinicalTrials.gov processed this record on May 21, 2013