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

February 19, 2008
September 17, 2009
March 2006
June 2010   (final data collection date for primary outcome measure)
Total bupivicaine used [ Time Frame: End of labor ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00810914 on ClinicalTrials.gov Archive Site
maternal satisfaction [ Time Frame: End of labor ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Patient Controlled Epidural Analgesia Versus Continuous Epidural Infusion: Obstetrical and Neonatal Outcomes
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Pain
  • Drug: bupivicaine epidural
    bupivicaine continuous epidural infusion
    Other Name: Marcaine
  • Drug: bupivicaine epidural infusion patient epidural
    bupivicaine
    Other Name: marcaine
  • Drug: bupivicaine
    patient controlled anesthesia only
    Other Name: marcaine
  • Experimental: 1
    Continuous epidural infusion of medication for method of pain relief
    Intervention: Drug: bupivicaine epidural
  • Experimental: 2
    continuous epidural infusion in conjuction with patient controlled anesthesia (PCA)
    Intervention: Drug: bupivicaine epidural infusion patient epidural
  • Experimental: 3
    patient controlled anesthesia only this arm has pt controlled medication delivery. (PCA)
    Intervention: Drug: bupivicaine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
270
December 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Early labor
  • Nulliparous

Exclusion Criteria:

  • Inductions
  • Breech
  • Contraindications to regional anesthesia
Female
18 Years and older
Yes
Contact: Christine Preslicka, RN 562-933-2755 cpreslicka@memorialcare.org
United States
 
NCT00810914
333-06, MHS 801001-R433306
No
Michael Haydon, MD, Women's Pavilion at Miller Children's Hospital
MemorialCare
Not Provided
Principal Investigator: Michael Haydon, MD Memorial care Health Sytem Physcian
MemorialCare
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP