Epidural Analgesia Versus IV Meperidine for Labor Pain Control

Labor Pain Clinical Trial

Official title:

Epidural Analgesia Versus IV Meperidine for Labor Pain Control. Objective Evaluation of the Pain Intensity Influence on the Autonomic Nervous System.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00296751
• Other study ID #: epiduralCTIL
• Status: Completed
• Phase: N/A
• First received: February 24, 2006
• Last updated: June 30, 2010
• Start date: March 2006
• Est. completion date: December 2006

Study information

• Verified date: April 2008
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Labor Pain

Intervention

Procedure:
• ECG recording

• Epidural catheter insertion

Drug:
• Intravenous meperidine injection

• Epidural Bupivacaine and fentanyl injection

Locations

Country	Name	City	State
Israel	Rambam - health care campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Three lead ECG monitoring for 10 minutes will be performed 30 minutes after the administration.