Epidural Analgesia Versus IV Meperidine for Labor Pain Control - Full Text View

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

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