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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00810914
Acronym
Epidural
Enrollment
270
Registered
2008-12-18
Start date
2006-03-31
Completion date
2010-12-31
Last updated
2009-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Patient controlled epidural anesthesia, Pain control in labor

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.

Interventions

DRUGbupivicaine epidural

bupivicaine continuous epidural infusion

DRUGbupivicaine epidural infusion patient epidural

bupivicaine

patient controlled anesthesia only

Sponsors

MemorialCare
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Early labor * Nulliparous

Exclusion criteria

* Inductions * Breech * Contraindications to regional anesthesia

Design outcomes

Primary

MeasureTime frame
Total bupivicaine usedEnd of labor

Secondary

MeasureTime frame
maternal satisfactionEnd of labor

Countries

United States

Contacts

Primary ContactChristine Preslicka, RN
cpreslicka@memorialcare.org562-933-2755

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026