Combined Spinal-Epidural Versus Traditional Labor Epidural - Full Text View

Purpose

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.

Condition	Intervention	Phase
Labour Pain	Drug: Bupivacaine and Fentanyl (for CSE) Drug: Bupivacaine and Fentanyl (for traditional epidural)	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Combined Spinal-Epidural Versus Traditional Labor Epidural: A Randomized, Controlled Trial Comparing Maternal and Fetal Effects

Resource links provided by NLM:

Drug Information available for: Fentanyl Fentanyl citrate Bupivacaine hydrochloride Bupivacaine

U.S. FDA Resources

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:

Adverse fetal effects: fetal bradycardia and abnormal fetal heart rate patterns [ Time Frame: during the 60 minutes after placement of analgesia ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Average change in systolic blood pressure [ Time Frame: during the 60 minutes after placement of analgesia ] [ Designated as safety issue: Yes ]
Average change in mean blood pressure [ Time Frame: during the 60 minutes after placement of analgesia ] [ Designated as safety issue: Yes ]
Blood pressure differences between the upper and lower extremities [ Time Frame: during the 60 minutes after placement of analgesia ] [ Designated as safety issue: Yes ]
Efficacy of analgesia as rated by the visual analog pain scale [ Time Frame: during the 60 minutes after analgesic placement ] [ Designated as safety issue: No ]
Pruritus [ Time Frame: through the first day following placement of analgesia ] [ Designated as safety issue: Yes ]
Incidence of hypotension [ Time Frame: during the 60 minutes after placement of analgesia ] [ Designated as safety issue: Yes ]
Patient satisfaction [ Time Frame: first day following placement of analgesia ] [ Designated as safety issue: No ]

Enrollment:	127
Study Start Date:	October 2003
Study Completion Date:	September 2006
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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: combined spinal-epidural labor analgesia
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: traditional epidural labor analgesia

Arms

Assigned Interventions

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:

combined spinal-epidural
labor analgesia

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:

traditional epidural
labor analgesia

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

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151346

Locations

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

Sponsors and Collaborators

Weill Medical College of Cornell University

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

More Information

No publications provided

Responsible Party:	Daniel W. Skupski, M.D., Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT00151346 History of Changes
Other Study ID Numbers:	0306006204 (0603-889)
Study First Received:	September 6, 2005
Last Updated:	March 17, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:

Epidural
Labour pain
Pregnant women
Epidural anesthesia

Labour, Obstetric
labor pain
labor, obstetric
labor analgesia

Additional relevant MeSH terms:

Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Bupivacaine
Fentanyl
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs

Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Narcotics
Analgesics
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 22, 2013