Combined Spinal-Epidural Versus Traditional Labor Epidural

Labour Pain Clinical Trial

Official title:

Combined Spinal-Epidural Versus Traditional Labor Epidural: A Randomized, Controlled Trial Comparing Maternal and Fetal Effects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00151346
• Other study ID #: 0306006204 (0603-889)
• Status: Completed
• Phase: Phase 4
• First received: September 6, 2005
• Last updated: March 17, 2008
• Start date: October 2003
• Est. completion date: September 2006

Study information

• Verified date: March 2008
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study to compare the use of spinal-epidural versus traditional labor epidural on maternal and fetal effects. The hope is to determine the safest and most effective epidural method of relieving pain during labor.

Description:

Combined spinal-epidural anesthesia (CSE) was developed to allow excellent pain control for the pregnant woman who arrives in advanced labor and does not have much time for the anesthetic to have its effect. This has been extended recently to women in all stages of labor because of its rapid and excellent control of pain. Recent case series comparing CSE with traditional epidural have shown a slight difference in the rate of hypotension and fetal bradycardia, with the CSE technique having a higher rate of both of these side effects. This study will compare the two techniques in a prospective, randomized method.

The aim is to compare the maternal and fetal effects of two neuraxial block techniques for pain control during labor, to document blood pressure changes in upper and lower extremities pre- and post- block placement, and to document side effects (e.g. pruritus) and patient satisfaction with both techniques.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Patient is able to read, understand and voluntarily sign the approved informed consent form (ICF) prior to any study- specific procedure;

• Must be between 18 to 50 years of age.

• Must be carrying a singleton fetus at term.

• Must have less than a body mass index of 40.

• Must be in labor, or is having a medical induction of labor.

Exclusion Criteria:

• Patient who has chronic renal disease, pre-existing hypertension, or pre-eclampsia.

• Patient who is undergoing an elective cesarean delivery

• Patient who has a presence of non-reassuring fetal status

• Patient who has an abnormal or non-reassuring fetal heart rate (FHR) pattern

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Labor Pain
• Labour Pain

Intervention

Drug:
• Bupivacaine and Fentanyl (for CSE)
Bupivacaine 0.25% x 1 cc + Fentanyl 20 mcg, followed by infusion of Bupivacaine 0.0625% with Fentanyl 2 mcg/mL at 12 cc/hr
• Bupivacaine and Fentanyl (for traditional epidural)
Bupivacaine 0.0625% with Fentanyl 2 mcg/mL x 15 cc, followed by infusion of Bupivacaine 0.0625% with Fentanyl 2 mcg/mL at 12 cc/hr

Locations

Country	Name	City	State
United States	New York-Presbyterian Hospital; Weill Medical College of Cornell	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	New York Presbyterian Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse fetal effects: fetal bradycardia and abnormal fetal heart rate patterns		during the 60 minutes after placement of analgesia	Yes
Secondary	Average change in systolic blood pressure		during the 60 minutes after placement of analgesia	Yes
Secondary	Average change in mean blood pressure		during the 60 minutes after placement of analgesia	Yes
Secondary	Blood pressure differences between the upper and lower extremities		during the 60 minutes after placement of analgesia	Yes
Secondary	Efficacy of analgesia as rated by the visual analog pain scale		during the 60 minutes after analgesic placement	No
Secondary	Pruritus		through the first day following placement of analgesia	Yes
Secondary	Incidence of hypotension		during the 60 minutes after placement of analgesia	Yes
Secondary	Patient satisfaction		first day following placement of analgesia	No