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

Not Applicable

• Conditions: Pain
• Interventions: Drug: bupivicaine epidural; Drug: bupivicaine epidural infusion patient epidural; Drug: bupivicaine

• Registration Number: NCT00810914
• Lead Sponsor: MemorialCare

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2008-02-19
• Study First Submitted QC: 2008-12-17
• Study First Posted: 2008-12-18
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-17
• Last Update Posted: 2009-09-18
• Primary Completion: 2010-06
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 270

Inclusion Criteria

• Early labor
• Nulliparous

Exclusion Criteria

• Inductions
• Breech
• Contraindications to regional anesthesia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	bupivicaine epidural	Continuous epidural infusion of medication for method of pain relief
2	bupivicaine epidural infusion patient epidural	continuous epidural infusion in conjuction with patient controlled anesthesia (PCA)
3	bupivicaine	patient controlled anesthesia only this arm has pt controlled medication delivery. (PCA)

Primary Outcome Measures

Name	Time	Method
Total bupivicaine used	End of labor

Secondary Outcome Measures

Name	Time	Method
maternal satisfaction	End of labor

Trial Locations

Locations (1)

Long Beach Memorial Medical Center; 🇺🇸 Long Beach, California, United States