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

September 17, 2009 updated by: MemorialCare

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

270

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Long Beach, California, United States, 90806
        • Recruiting
        • Long Beach Memorial Medical Center
        • Contact:
        • Principal Investigator:
          • Michael Haydon, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Early labor
  • Nulliparous

Exclusion Criteria:

  • Inductions
  • Breech
  • Contraindications to regional anesthesia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Continuous epidural infusion of medication for method of pain relief
Drug: bupivicaine epidural
bupivicaine continuous epidural infusion
Other Names:
  • Marcaine
EXPERIMENTAL: 2
continuous epidural infusion in conjuction with patient controlled anesthesia (PCA)
Drug: bupivicaine epidural infusion patient epidural
bupivicaine
Other Names:
  • marcaine
EXPERIMENTAL: 3
patient controlled anesthesia only this arm has pt controlled medication delivery. (PCA)
Drug: bupivicaine
patient controlled anesthesia only
Other Names:
  • marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total bupivicaine used
Time Frame: End of labor
End of labor

Secondary Outcome Measures

Outcome Measure
Time Frame
maternal satisfaction
Time Frame: End of labor
End of labor

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MemorialCare

Investigators

  • Principal Investigator: Michael Haydon, MD, Memorial care Health Sytem Physcian

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (ANTICIPATED)

June 1, 2010

Study Completion (ANTICIPATED)

December 1, 2010

Study Registration Dates

First Submitted

February 19, 2008

First Submitted That Met QC Criteria

December 17, 2008

First Posted (ESTIMATE)

December 18, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 18, 2009

Last Update Submitted That Met QC Criteria

September 17, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 333-06
  • MHS 801001-R433306

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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