Labour Pain
Conditions
Keywords
Epidural, Labour pain, Pregnant women, Epidural anesthesia, Labour, Obstetric, labor pain, labor, obstetric, labor analgesia
Brief summary
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.
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.
Interventions
DRUGBupivacaine 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
DRUGBupivacaine 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
Sponsors
New York Presbyterian Hospital
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse fetal effects: fetal bradycardia and abnormal fetal heart rate patterns | during the 60 minutes after placement of analgesia |
Secondary
| Measure | Time frame |
|---|---|
| Patient satisfaction | first day following 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 |
| 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 |
| Average change in systolic blood pressure | during the 60 minutes after placement of analgesia |
Countries
United States
Outcome results
None listed