Epidural Analgesia Versus IV Meperidine for Labor Pain Control
Information source: Rambam Health Care Campus
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Labor Pain
Intervention: ECG recording (Procedure); Epidural catheter insertion (Procedure); Intravenous meperidine injection (Drug); Epidural Bupivacaine and fentanyl injection (Drug)
Phase: N/A
Status: Completed
Sponsored by: Rambam Health Care Campus Official(s) and/or principal investigator(s):
Amir Weissman, MD, Study Director, Affiliation: Rambam Health Care Campus
Olga Torchov, MD, Principal Investigator, Affiliation: Rambam Health Care Campus
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.
Clinical Details
Official title: Epidural Analgesia Versus IV Meperidine for Labor Pain Control. Objective Evaluation of the Pain Intensity Influence on the Autonomic Nervous System.
Study design: Other, Randomized, Open Label, Active Control, Parallel Assignment
Primary outcome: Three lead ECG monitoring for 10 minutes will be performed 30 minutes after the administration.
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
Minimum age: 20 Years.
Maximum age: 40 Years.
Gender(s): Female.
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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Locations and Contacts
Rambam - health care campus, Haifa 31096, Israel
Additional Information
Starting date: March 2006
Ending date: December 2006
Last updated: April 18, 2008
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