Epidural Analgesia Versus IV Meperidine for Labor Pain Control
This study has been completed.
Sponsor:
Rambam Health Care Campus
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
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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:
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) |
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 (Adult) |
| 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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00296751
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
| 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 Sensory System Agents Peripheral Nervous System Agents Analgesics, Opioid Narcotics Analgesics Adjuvants, Anesthesia Anesthetics, Intravenous Anesthetics, General |
ClinicalTrials.gov processed this record on September 30, 2016