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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by MemorialCare.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
MemorialCare
ClinicalTrials.gov Identifier:
NCT00810914
First received: February 19, 2008
Last updated: September 17, 2009
Last verified: September 2009
  Purpose

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 Intervention
Pain
Drug: bupivicaine epidural
Drug: bupivicaine epidural infusion patient epidural
Drug: bupivicaine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Official Title: Patient Controlled Epidural Infusion Vs. Continuous Epidural Infusion: Obstetrical and Neonatal Outcomes

Resource links provided by NLM:


Further study details as provided by MemorialCare:

Primary Outcome Measures:
  • Total bupivicaine used [ Time Frame: End of labor ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • maternal satisfaction [ Time Frame: End of labor ] [ Designated as safety issue: No ]

Estimated Enrollment: 270
Study Start Date: March 2006
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
bupivicaine
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Early labor
  • Nulliparous

Exclusion Criteria:

  • Inductions
  • Breech
  • Contraindications to regional anesthesia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00810914

Contacts
Contact: Christine Preslicka, RN 562-933-2755 cpreslicka@memorialcare.org

Locations
United States, California
Long Beach Memorial Medical Center Recruiting
Long Beach, California, United States, 90806
Contact: Christine Preslicka, RN    562-933-2750    cpreslicka@memorialcare.org   
Principal Investigator: Michael Haydon, MD         
Sponsors and Collaborators
MemorialCare
Investigators
Principal Investigator: Michael Haydon, MD Memorial care Health Sytem Physcian
  More Information

No publications provided

Responsible Party: Michael Haydon, MD, Women's Pavilion at Miller Children's Hospital
ClinicalTrials.gov Identifier: NCT00810914     History of Changes
Other Study ID Numbers: 333-06, MHS 801001-R433306
Study First Received: February 19, 2008
Last Updated: September 17, 2009
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Anesthetics
Bupivacaine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 26, 2014