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| ID | Type | Description | Link |
|---|---|---|---|
| MHS 801001-R433306 |
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The investigators intend to perform a large randomized trial using standardized obstetrical and anesthetic practice at a single institution to determine the effects of patient controlled epidural analgesia on obstetrical and neonatal outcomes.
Women in their first pregnancy in spontaneous labor desiring epidural anesthesia will be randomized to one of three groups. Each group will initially be given intrathecal bolus. Before and 30 minutes after the initial bolus, the patient's verbal pain score will be recorded. The continuous epidural infusion group (Group I) will be started immediately on a continuous pump infusion.They will also have the opportunity to give a PCA bolus Finally, the patient controlled epidural group (Group III) will be able to give a bolus every 20 minutes with no continuous infusion. Each group will also be allowed 2 boluses,by the anesthesia staff in the event that their pain is not controlled by the indicated study medication. An hourly evaluation of verbal pain score and maternal mobility will be recorded. After delivery, obstetrical outcomes, neonatal outcomes, anesthesia interventions, and patient satisfaction questionnaires will then be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Continuous epidural infusion of medication for method of pain relief |
|
| 2 | Experimental | continuous epidural infusion in conjuction with patient controlled anesthesia (PCA) |
|
| 3 | Experimental | patient controlled anesthesia only this arm has pt controlled medication delivery. (PCA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bupivicaine epidural | Drug | bupivicaine continuous epidural infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total bupivicaine used | End of labor |
| Measure | Description | Time Frame |
|---|---|---|
| maternal satisfaction | End of labor |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christine Preslicka, RN | Contact | 562-933-2755 | cpreslicka@memorialcare.org |
| Name | Affiliation | Role |
|---|---|---|
| Michael Haydon, MD | Memorial care Health Sytem Physcian | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Long Beach Memorial Medical Center | Recruiting | Long Beach | California | 90806 | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| bupivicaine epidural infusion patient epidural | Drug | bupivicaine |
|
|
| bupivicaine | Drug | patient controlled anesthesia only |
|
|
| D000588 |
| Amines |