Clinical trial NCT00151346: Combined Spinal-Epidural Versus Traditional Labor Epidural
Official title: Combined Spinal-Epidural Versus Traditional Labor Epidural: A Randomized, Controlled Trial Comparing Maternal and Fetal Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Labour Pain
Keywords: Epidural
Labour pain
Pregnant women
Epidural anesthesia
Labour, Obstetric
labor pain
labor, obstetric
labor analgesia
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: New York Presbyterian Hospital
First posted: 2005-09-08
Enrollment: 127
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Adverse fetal effects: fetal bradycardia and abnormal fetal heart rate patterns
timeFrame: during the 60 minutes after placement of analgesia
Secondary outcomes:
measure: Average change in systolic blood pressure
timeFrame: during the 60 minutes after placement of analgesia
measure: Average change in mean blood pressure
timeFrame: during the 60 minutes after placement of analgesia
measure: Blood pressure differences between the upper and lower extremities
timeFrame: during the 60 minutes after placement of analgesia
measure: Efficacy of analgesia as rated by the visual analog pain scale
timeFrame: during the 60 minutes after analgesic placement
measure: Pruritus
timeFrame: through the first day following placement of analgesia
measure: Incidence of hypotension
timeFrame: during the 60 minutes after placement of analgesia
measure: Patient satisfaction
timeFrame: first day following placement of analgesia
Other outcomes:
Locations:
city: New York
country: United States
facility: New York-Presbyterian Hospital; Weill Medical College of Cornell
state: New York
Study officials:
affiliation: Obstetrics & Gynecology; Weill Medical College of Cornell - New York Presbyterian Hospital
name: Daniel W. Skupski, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Anesthesiology; Weill Medical College of Cornell - New York Presbyterian Hospital
name: Klaus Kjaer-Pedersen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: