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| Sponsored by: |
MemorialCare |
|---|---|
| Information provided by: | MemorialCare |
| ClinicalTrials.gov Identifier: | NCT00810914 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Pain |
Drug: bupivicaine epidural Drug: bupivicaine epidural infusion patient epidural Drug: bupivicaine |
| Study Type: | Interventional |
| Study Design: | Randomized, Double Blind (Subject, Caregiver), Dose Comparison, Parallel Assignment, Efficacy Study |
| Official Title: | Patient Controlled Epidural Infusion Vs. Continuous Epidural Infusion: Obstetrical and Neonatal Outcomes |
| Estimated Enrollment: | 270 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Continuous epidural infusion
|
Drug: bupivicaine epidural
bupivicaine continuous epidural infusion
|
|
2: Experimental
continuous epidural infusion and patient controlled anesthesia
|
Drug: bupivicaine epidural infusion patient epidural
bupivicaine
|
|
3: Experimental
patient controlled anesthesia only
|
Drug: bupivicaine
patient controlled anesthesia only
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Christine Preslicka, RN | 562-933-2755 | cpreslicka@memorialcare.org |
| United States, California | |
| Long Beach Memorial Medical Center | Recruiting |
| Long Beach, California, United States, 90806 | |
| Contact: Christine Preslicka, RN 562-933-2750 cpreslicka@memorialcare.org | |
| Principal Investigator: Michael Haydon, MD | |
| Principal Investigator: | Michael Haydon, MD | Memorial care Health Sytem Physcian |
More Information
| Responsible Party: | Women's Pavilion at Miller Children's Hospital ( Michael Haydon, MD ) |
| Study ID Numbers: | 333-06, MHS 801001-R433306 |
| Study First Received: | February 19, 2008 |
| Last Updated: | December 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00810914 |
| Health Authority: | United States: Institutional Review Board |
|
Patient controlled epidural anesthesia Pain control in labor |
|
Bupivacaine Pain |
|
Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Central Nervous System Depressants Anesthetics |
Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions Anesthetics, Local |
