Epidural Analgesia Versus IV Meperidine for Labor Pain Control
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.
Procedure: ECG recording
Procedure: Epidural catheter insertion
Drug: Intravenous meperidine injection
Drug: Epidural Bupivacaine and fentanyl injection
|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.|
- Three lead ECG monitoring for 10 minutes will be performed 30 minutes after the administration.
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00296751
|Rambam - health care campus|
|Haifa, Israel, 31096|
|Study Director:||Amir Weissman, MD||Rambam Health Care Campus|
|Principal Investigator:||Olga Torchov, MD||Rambam Health Care Campus|