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Combined Spinal-Epidural Versus Traditional Labor Epidural

NCT ID: NCT00151346

Last Updated: 2008-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2006-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Labour Pain

Keywords

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Epidural Labour pain Pregnant women Epidural anesthesia Labour, Obstetric labor pain labor, obstetric labor analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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CSE

Subjects assigned to this group will receive "combined spinal-epidural" (CSE) to relieve pain during labor. For CSE, subjects receive a small amount of a local anesthetic and a small amount of a narcotic pain killer directly into the spinal canal (a smaller amount than is given for traditional epidural), followed by a small amount of both of these medications that is continuously infused into the epidural space through a catheter that is left in place. CSE is not experimental.

Group Type ACTIVE_COMPARATOR

Bupivacaine and Fentanyl (for CSE)

Intervention Type DRUG

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

Traditional Epidural

Subjects assigned to this group will receive "traditional epidural" to relieve pain during labor. For the traditional epidural, subjects receive a small amount of a local anesthetic and a small amount of a narcotic pain killer into the epidural space, followed by a small amount of both of these medications that is continuously infused into the epidural space through a catheter that is left in place. The traditional epidural is not experimental.

Group Type ACTIVE_COMPARATOR

Bupivacaine and Fentanyl (for traditional epidural)

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

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

Intervention Type DRUG

Other Intervention Names

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combined spinal-epidural labor analgesia traditional epidural labor analgesia

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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New York Presbyterian Hospital

OTHER

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Weill Medical College of Cornell University

Principal Investigators

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Daniel W. Skupski, M.D.

Role: PRINCIPAL_INVESTIGATOR

Obstetrics & Gynecology; Weill Medical College of Cornell - New York Presbyterian Hospital

Klaus Kjaer-Pedersen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Anesthesiology; Weill Medical College of Cornell - New York Presbyterian Hospital

Locations

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New York-Presbyterian Hospital; Weill Medical College of Cornell

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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0306006204 (0603-889)

Identifier Type: -

Identifier Source: org_study_id