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

Pain Clinical Trial

— Epidural  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00810914
• Other study ID #: 333-06
• Secondary ID: MHS 801001-R4333
• Status: Recruiting
• Phase: N/A
• First received: February 19, 2008
• Last updated: September 17, 2009
• Start date: March 2006
• Est. completion date: December 2010

Study information

• Verified date: September 2009
• Source: MemorialCare
• Contact: Christine Preslicka, RN
• Phone: 562-933-2755
• Email: cpreslicka[@]memorialcare.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: December 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Early labor

• Nulliparous

Exclusion Criteria:

• Inductions

• Breech

• Contraindications to regional anesthesia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver)

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• bupivicaine epidural
bupivicaine continuous epidural infusion
• bupivicaine epidural infusion patient epidural
bupivicaine
• bupivicaine
patient controlled anesthesia only

Locations

Country	Name	City	State
United States	Long Beach Memorial Medical Center	Long Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
MemorialCare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total bupivicaine used		End of labor	No
Secondary	maternal satisfaction		End of labor	No