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
Labor, Obstetric Labor Pain Epidural anesthesia	Drug: Bupivacaine & Fentanyl	Phase IV

Further Study Details: 

Primary Outcomes: Adverse fetal effects: fetal bradycardia & abnormal fetal heart rate patterns during the 60 minutes after placement of analgesia
Secondary Outcomes: Average change in systolic blood pressure; Average change in mean blood pressure; Blood pressure differences between the upper & lower extremities; Efficacy of analgesia as rated by the visual analog pain scale during the 60 minutes after analgesic placement; Pruritus; Incidence of hypotension; Patient satisfaction
Expected Total Enrollment:  200

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.

Ages Eligible for Study:  18 Years   -   50 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• Pt. is able to read, understand & voluntarily sign the approved ICF prior to any study- specific procedure;
• Pt. must be between 18 to 50 years of age.
• Pt. must be carrying a singleton fetus at term.
• Pt. must have less than a body mass index of 40.
• Pt. must be in labor, or is having a medical induction of labor.

Exclusion Criteria:

• Pt. who has chronic renal disease, pre-existing hypertension, or pre-eclampsia.
• Pt. who is undergoing an elective cesarean delivery
• Pt. who has a presence of non reassuring fetal status
• Pt who has an abnormal or non-reassuring fetal heart rate (FHR) pattern

Please refer to this study by ClinicalTrials.gov identifier  NCT00151346

Susan L. Kourpanidis, B.A.      212-746-2952    slk2001@med.cornell.edu
Daniel Skupski, M.D.      212-746-3069    dwskupsk@med.cornell.edu

New York
      New York-Presbyterian Hospital; Weill Medical College of Cornell, New York,  New York,  10021,  United States; Recruiting

Study chairs or principal investigators

Daniel W. Skupski, M.D.,  Principal Investigator,  Obstetrics & Gynecology; Weill Medical College of Cornell - New York Presbyterian Hospital   
Klaus Kjaer, M.D.,  Principal Investigator,  Anesthesiology; Weill Medical College of Cornell - New York Presbyterian Hospital   

Study ID Numbers:  0603-889
Last Updated:  September 7, 2005
Record first received:  September 6, 2005
ClinicalTrials.gov Identifier:  NCT00151346
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13