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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00810914
Recruitment Status : Unknown
Verified September 2009 by MemorialCare.
Recruitment status was:  Recruiting
First Posted : December 18, 2008
Last Update Posted : September 18, 2009
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Pain Drug: bupivicaine epidural Drug: bupivicaine epidural infusion patient epidural Drug: bupivicaine Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Official Title: Patient Controlled Epidural Infusion Vs. Continuous Epidural Infusion: Obstetrical and Neonatal Outcomes
Study Start Date : March 2006
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Total bupivicaine used [ Time Frame: End of labor ]

Secondary Outcome Measures :
  1. maternal satisfaction [ Time Frame: End of labor ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Early labor
  • Nulliparous

Exclusion Criteria:

  • Inductions
  • Breech
  • Contraindications to regional anesthesia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00810914

Contact: Christine Preslicka, RN 562-933-2755

United States, California
Long Beach Memorial Medical Center Recruiting
Long Beach, California, United States, 90806
Contact: Christine Preslicka, RN    562-933-2750   
Principal Investigator: Michael Haydon, MD         
Sponsors and Collaborators
Principal Investigator: Michael Haydon, MD Memorial care Health Sytem Physcian

Responsible Party: Michael Haydon, MD, Women's Pavilion at Miller Children's Hospital Identifier: NCT00810914     History of Changes
Other Study ID Numbers: 333-06
MHS 801001-R433306
First Posted: December 18, 2008    Key Record Dates
Last Update Posted: September 18, 2009
Last Verified: September 2009

Keywords provided by MemorialCare:
Patient controlled epidural anesthesia
Pain control in labor

Additional relevant MeSH terms:
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents