MedTrace Logo

Parturient Controlled Epidural Analgesia (PCEA) With or Without a Basal Infusion for Early Labor

NCT00871442 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2015-11-18

No results posted yet for this study

Summary

Patient Controlled Epidural Analgesia is a widely used and effective means of adult pain management. However, Parturient Controlled Epidural Analgesia (PCEA) is a relatively new approach to pain control for the women in labor. With the recent acquisition of new PCEA technology at Baystate Medical Center it is now possible to make this patient controlled technology available on the Labor and Delivery unit. This study is designed to determine whether there is a difference in analgesia, side effects, or analgesic duration in patients who receive a bupivacaine and fentanyl PCEA for management of labor pain. The present study hypothesizes that an analgesic protocol that includes a basal infusion rate in addition to a bolus dose controlled by the patient will have a longer analgesic duration than a pump protocol that does not have a basal infusion added to a bolus dose controlled by the patient.

Methods:The study population will consist of 100 adult obstetrical patients greater than 36 weeks gestation who request labor analgesia. Patients greater than 5 cm cervical dilation, patients who have received intravenous opioid agonists, or patients with a contraindication to fentanyl will be excluded. Patients with pre-eclampsia are also excluded.

One of the following PCEA treatment protocols will be started in a randomized, double blind fashion.PCEA solution: Bupivacaine 0.0625% with fentanyl 2 mcg/ml Group 1: Basal Infusion: 0 ml/hr; Bolus 10 ml q 30min prn (10ml demand dose with 30min lockout) Group 2: Basal Infusion: 10 ml/h; Bolus 5 ml q 30min prn (5ml demand dose with 30min lockout) If the patient does not obtain relief within 30 minutes, the epidural catheter will be dosed with a local anesthetic and the study will be concluded. The patients without pain relief within 30 minutes are considered to have failed epidurals and are dropped from the study and the analysis. Following achievement of satisfactory analgesia, the patient will be evaluated every 30 minutes until they request additional analgesics. The study will "end" at this point, and the patient will be treated at the discretion of the anesthesiologist.

Conditions

  • Labor Pain

Interventions

OTHER

No Basal Infusion

Group 1: Basal Infusion: 0 ml/hr; Bolus 10 ml q 30min prn (10ml demand dose with 30min lockout)

OTHER

Basal infusion

Group 2 Basal Infusion: 0 ml/hr; Bolus 10 ml q 30min prn (10ml demand dose with 30min lockout)

DRUG

PCEA solution (bupivacaine and fentanyl)

PCEA solution: Bupivacaine 0.0625% with fentanyl 2 mcg/ml

Sponsors & Collaborators

  • Neil Roy Connelly, MD

    lead OTHER

Principal Investigators

  • Neil Roy Connelly, MD · Baystate Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00871442 on ClinicalTrials.gov