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Completed

NCT Number: NCT00151346

Combined Spinal-Epidural Versus Traditional Labor Epidural

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

New York-Presbyterian Hospital; Weill Medical College of Cornell

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine and Fentanyl (for CSE)

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

Other names: combined spinal-epidural, labor analgesia

Bupivacaine and Fentanyl (for traditional epidural)

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

Other names: traditional epidural, labor analgesia

Primary outcomes

  1. Adverse fetal effects: fetal bradycardia and abnormal fetal heart rate patterns

    Time frame: during the 60 minutes after placement of analgesia

Secondary outcomes

  1. Average change in systolic blood pressure

    Time frame: during the 60 minutes after placement of analgesia

  2. Average change in mean blood pressure

    Time frame: during the 60 minutes after placement of analgesia

  3. Blood pressure differences between the upper and lower extremities

    Time frame: during the 60 minutes after placement of analgesia

  4. Efficacy of analgesia as rated by the visual analog pain scale

    Time frame: during the 60 minutes after analgesic placement

  5. Pruritus

    Time frame: through the first day following placement of analgesia

  6. Incidence of hypotension

    Time frame: during the 60 minutes after placement of analgesia

  7. Patient satisfaction

    Time frame: first day following placement of analgesia

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • New York Presbyterian Hospital

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Sep 8, 2005
Registry last updated
Mar 18, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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