NCT00810914

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
270

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Mar 2006

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2008

Completed
10 months until next milestone

First Posted

Study publicly available on registry

December 18, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

September 18, 2009

Status Verified

September 1, 2009

Enrollment Period

4.3 years

First QC Date

February 19, 2008

Last Update Submit

September 17, 2009

Conditions

Pain

Keywords

Patient controlled epidural anesthesiaPain control in labor

Outcome Measures

Primary Outcomes (1)

  • Total bupivicaine used

    End of labor

Secondary Outcomes (1)

  • maternal satisfaction

    End of labor

Study Arms (3)

1

EXPERIMENTAL

Continuous epidural infusion of medication for method of pain relief

Drug: bupivicaine epidural

2

EXPERIMENTAL

continuous epidural infusion in conjuction with patient controlled anesthesia (PCA)

Drug: bupivicaine epidural infusion patient epidural

3

EXPERIMENTAL

patient controlled anesthesia only this arm has pt controlled medication delivery. (PCA)

Drug: bupivicaine

Interventions

bupivicaine epiduralDRUG

bupivicaine continuous epidural infusion

Also known as: Marcaine
1
bupivicaine epidural infusion patient epiduralDRUG

bupivicaine

Also known as: marcaine
2
bupivicaineDRUG

patient controlled anesthesia only

Also known as: marcaine
3

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Early labor
  • Nulliparous

You may not qualify if:

  • Inductions
  • Breech
  • Contraindications to regional anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Long Beach Memorial Medical Center

Long Beach, California, 90806, United States

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Michael Haydon, MD

    Memorial care Health Sytem Physcian

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Preslicka, RN

CONTACT

562-933-2755cpreslicka@memorialcare.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 19, 2008

First Posted

December 18, 2008

Study Start

March 1, 2006

Primary Completion

June 1, 2010

Study Completion

December 1, 2010

Last Updated

September 18, 2009

Record last verified: 2009-09

Locations

US(1)