Patient Controlled Epidural Analgesia Versus Continuous Epidural Infusion: Obstetrical and Neonatal Outcomes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Patient Controlled Epidural Infusion Vs. Continuous Epidural Infusion: Obstetrical and Neonatal Outcomes

Conditions
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Pain

Intervention / Treatment
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* Drug: bupivicaine epidural
* Drug: bupivicaine epidural infusion patient epidural
* Drug: bupivicaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Early labor Nulliparous Exclusion Criteria: Inductions Breech Contraindications to regional anesthesia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Continuous epidural infusion of medication for method of pain relief | Drug: bupivicaine epidural<br>* bupivicaine continuous epidural infusion<br>* Other names: Marcaine;|
| Experimental: 2<br>continuous epidural infusion in conjuction with patient controlled anesthesia (PCA) | Drug: bupivicaine epidural infusion patient epidural<br>* bupivicaine<br>* Other names: marcaine;|
| Experimental: 3<br>patient controlled anesthesia only this arm has pt controlled medication delivery. (PCA) | Drug: bupivicaine<br>* patient controlled anesthesia only<br>* Other names: marcaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total bupivicaine used |  | End of labor | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maternal satisfaction |  | End of labor | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient controlled epidural anesthesia, Pain control in labor