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

Pain Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver)

Related Conditions & MeSH terms

• Pain

• NCT number: NCT00810914
• Study type: Interventional
• Source: MemorialCare
• Contact: Christine Preslicka, RN
• Phone: 562-933-2755
• Email: cpreslicka@memorialcare.org
• Status: Recruiting
• Phase: N/A
• Start date: March 2006
• Completion date: December 2010