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

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

Study Type:	Interventional
Study Design:	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.

Resource links provided by NLM:

Drug Information available for: Meperidine hydrochloride Meperidine Bupivacaine hydrochloride Bupivacaine Fentanyl

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

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

Study placed in the following topic categories:

Fentanyl
Adjuvants, Immunologic
Anesthetics
Central Nervous System Depressants
Narcotics
Pain
Anesthetics, Local
Meperidine

Signs and Symptoms
Labor Pain
Neurologic Manifestations
Bupivacaine
Peripheral Nervous System Agents
Analgesics
Analgesics, Opioid

Additional relevant MeSH terms:

Nervous System Diseases
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Narcotics
Pain
Anesthetics, Local
Pharmacologic Actions
Meperidine
Adjuvants, Anesthesia

Signs and Symptoms
Sensory System Agents
Therapeutic Uses
Labor Pain
Neurologic Manifestations
Bupivacaine
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on July 02, 2009