Combined Spinal-Epidural Versus Traditional Labor Epidural

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

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.

Study Overview

• Status: Completed
• Conditions: Labour Pain
• Intervention / Treatment: Drug: Bupivacaine and Fentanyl (for CSE); Drug: Bupivacaine and Fentanyl (for traditional epidural)

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.

• Study Type: Interventional
• Enrollment (Actual): 127
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • New York-Presbyterian Hospital; Weill Medical College of Cornell

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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; Other Names: labor analgesia; combined spinal-epidural
Active Comparator: 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.	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; Other Names: labor analgesia; traditional epidural

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse fetal effects: fetal bradycardia and abnormal fetal heart rate patterns	during the 60 minutes after placement of analgesia

Secondary Outcome Measures

Outcome Measure	Time Frame
Average change in systolic blood pressure	during the 60 minutes after placement of analgesia
Average change in mean blood pressure	during the 60 minutes after placement of analgesia
Blood pressure differences between the upper and lower extremities	during the 60 minutes after placement of analgesia
Efficacy of analgesia as rated by the visual analog pain scale	during the 60 minutes after analgesic placement
Pruritus	through the first day following placement of analgesia
Incidence of hypotension	during the 60 minutes after placement of analgesia
Patient satisfaction	first day following placement of analgesia

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: New York Presbyterian Hospital
• Investigators: Principal Investigator: Daniel W. Skupski, M.D., Obstetrics & Gynecology; Weill Medical College of Cornell - New York Presbyterian Hospital; Principal Investigator: Klaus Kjaer-Pedersen, M.D., Anesthesiology; Weill Medical College of Cornell - New York Presbyterian Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2003
• Primary Completion (Actual): September 1, 2006
• Study Completion (Actual): September 1, 2006

Study Registration Dates

• First Submitted: September 6, 2005
• First Submitted That Met QC Criteria: September 7, 2005
• First Posted (Estimate): September 8, 2005

Study Record Updates

• Last Update Posted (Estimate): March 18, 2008
• Last Update Submitted That Met QC Criteria: March 17, 2008
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Keywords: Epidural; labor pain; Epidural anesthesia; labor, obstetric; Pregnant women; labor analgesia; Labour pain; Labour, Obstetric
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Bupivacaine
• Other Study ID Numbers: 0306006204 (0603-889)