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

NCT ID: NCT00810914

Last Updated: 2009-09-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2010-12-31

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.

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

1

Continuous epidural infusion of medication for method of pain relief

Group Type: EXPERIMENTAL

bupivicaine epidural

Intervention Type: DRUG

bupivicaine continuous epidural infusion

2

continuous epidural infusion in conjuction with patient controlled anesthesia (PCA)

Group Type: EXPERIMENTAL

bupivicaine epidural infusion patient epidural

Intervention Type: DRUG

bupivicaine

3

patient controlled anesthesia only this arm has pt controlled medication delivery. (PCA)

Group Type: EXPERIMENTAL

bupivicaine

Intervention Type: DRUG

patient controlled anesthesia only

Interventions

bupivicaine epidural

bupivicaine continuous epidural infusion

Intervention Type: DRUG

bupivicaine epidural infusion patient epidural

bupivicaine

Intervention Type: DRUG

bupivicaine

patient controlled anesthesia only

Intervention Type: DRUG

Other Intervention Names

Marcaine; marcaine; marcaine

Eligibility Criteria

Inclusion Criteria

• Early labor
• Nulliparous

Exclusion Criteria

• Inductions
• Breech
• Contraindications to regional anesthesia

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

MemorialCare

OTHER

Sponsor Role: lead

Responsible Party

Women's Pavilion at Miller Children's Hospital

Principal Investigators

Michael Haydon, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial care Health Sytem Physcian

Locations

Long Beach Memorial Medical Center

Long Beach, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Christine Preslicka, RN

Role: CONTACT

cpreslicka@memorialcare.org

562-933-2755

Facility Contacts

Christine Preslicka, RN

Role: primary

cpreslicka@memorialcare.org

562-933-2750

Other Identifiers

MHS 801001-R433306

Identifier Type: -

Identifier Source: secondary_id

333-06

Identifier Type: -

Identifier Source: org_study_id