Combined Spinal-Epidural Versus Traditional Labor Epidural

Weill Cornell Medicine (WCM)

Status and phase: Completed; Phase 4

Conditions: Labour Pain

Treatments: Drug: Bupivacaine and Fentanyl (for traditional epidural); Drug: Bupivacaine and Fentanyl (for CSE)

Study type: Interventional

Funder types: Other

Identifiers

NCT00151346

0306006204 (0603-889)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 127 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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127 participants in 2 patient groups

CSE

Active Comparator group

Description:

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.

Treatment:

Drug: Bupivacaine and Fentanyl (for CSE)

Traditional Epidural

Active Comparator group

Description:

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.

Treatment:

Drug: Bupivacaine and Fentanyl (for traditional epidural)