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| Name | Class |
|---|---|
| New York Presbyterian Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSE | Active Comparator | 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. |
|
| Traditional Epidural | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine and Fentanyl (for CSE) | Drug | 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse fetal effects: fetal bradycardia and abnormal fetal heart rate patterns | during the 60 minutes after placement of analgesia |
| Measure | Description | 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York-Presbyterian Hospital; Weill Medical College of Cornell | New York | New York | 10065 | United States |
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| ID | Term |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Bupivacaine and Fentanyl (for traditional epidural) | Drug | 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 |
|
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| 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 |
| D000588 |
| Amines |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |