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

MemorialCare

Status: Unknown

Conditions: Pain

Treatments: Drug: bupivicaine epidural infusion patient epidural; Drug: bupivicaine epidural; Drug: bupivicaine

Study type: Interventional

Funder types: Other

Identifiers

NCT00810914

MHS 801001-R433306

333-06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 270 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Early labor
• Nulliparous

Exclusion criteria

• Inductions
• Breech
• Contraindications to regional anesthesia

Trial design

270 participants in 3 patient groups

1

Experimental group

Description:

Continuous epidural infusion of medication for method of pain relief

Treatment:

Drug: bupivicaine epidural

2

Experimental group

Description:

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

Treatment:

Drug: bupivicaine epidural infusion patient epidural

3

Experimental group

Description:

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

Treatment:

Drug: bupivicaine