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

This study has been withdrawn prior to enrollment.
(We decided that the study would not substantially add to existing contributions in the literature)
Sponsor:
Information provided by:
Baystate Medical Center
ClinicalTrials.gov Identifier:
NCT00871442
First received: March 27, 2009
Last updated: July 31, 2009
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Labor Pain
Other: No Basal Infusion
Other: Basal infusion
Drug: PCEA solution (bupivacaine and fentanyl)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Parturient Controlled Epidural Analgesia (PCEA) With or Without a Basal Infusion for Early Labor

Resource links provided by NLM:


Further study details as provided by Baystate Medical Center:

Primary Outcome Measures:
  • Analgesic duration [ Time Frame: request for analgesia ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2009
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: No Basal Infusion

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)

Other: No Basal Infusion
Group 1: Basal Infusion: 0 ml/hr; Bolus 10 ml q 30min prn (10ml demand dose with 30min lockout)
Other Names:
  • epidural infusion
  • bupivicaine
  • patient controlled epidural anesthesia (PCEA)
  • PCEA pump settings
Drug: PCEA solution (bupivacaine and fentanyl)
PCEA solution: Bupivacaine 0.0625% with fentanyl 2 mcg/ml
Active Comparator: Basal Infusion

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

Group 2: Basal Infusion: 10 ml/hr; Bolus 5 ml q 30min prn (5ml 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)
Other Names:
  • epidural infusion
  • bupivicaine
  • patient controlled epidural anesthesia (PCEA)
  • PCEA pump settings
Drug: PCEA solution (bupivacaine and fentanyl)
PCEA solution: Bupivacaine 0.0625% with fentanyl 2 mcg/ml

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The study population will consist of 100 adult obstetrical patients greater than 36 weeks gestation who request labor analgesia.

Exclusion Criteria:

  • Patients greater than 5 cm cervical dilation,
  • Patients who have received intravenous opioid agonists,
  • Patients with a contraindication to fentanyl, OR
  • Patients with pre-eclampsia are also excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00871442

Locations
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
Sponsors and Collaborators
Baystate Medical Center
Investigators
Principal Investigator: Neil Roy Connelly, MD Baystate Medical Center
  More Information

No publications provided

Responsible Party: Neil Roy Connelly, MD, Baystate Medical Center
ClinicalTrials.gov Identifier: NCT00871442     History of Changes
Other Study ID Numbers: IRB09-017
Study First Received: March 27, 2009
Last Updated: July 31, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Baystate Medical Center:
PCEA
labor and delivery
pain
epidural
anesthesia
pregnant women

Additional relevant MeSH terms:
Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anesthetics
Bupivacaine
Fentanyl
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Narcotics
Analgesics
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid

ClinicalTrials.gov processed this record on July 23, 2014