New York-Presbyterian Hospital; Weill Medical College of Cornell
New York, 10065, United States
NCT Number: NCT00151346
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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Notify Me18 year–50 year
Female
Interventional
Phase 4
New York, 10065, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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
Time frame: during the 60 minutes after placement of analgesia
Time frame: during the 60 minutes after placement of analgesia
Time frame: during the 60 minutes after placement of analgesia
Time frame: during the 60 minutes after placement of analgesia
Time frame: during the 60 minutes after analgesic placement
Time frame: through the first day following placement of analgesia
Time frame: during the 60 minutes after placement of analgesia
Time frame: first day following placement of analgesia
Weill Medical College of Cornell University
Other
Combined Spinal-Epidural Versus Traditional Labor Epidural: A Randomized, Controlled Trial Comparing Maternal and Fetal Effects
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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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