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

• ClinicalTrials.gov Identifier: NCT00871442
• Recruitment Status: Withdrawn
• First Posted: March 30, 2009
• Last Update Posted: November 18, 2015
• Sponsor: Neil Roy Connelly, MD
• Information provided by (Responsible Party): Neil Roy Connelly, MD, Baystate Medical Center

Study Description

Brief 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.

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

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Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Parturient Controlled Epidural Analgesia (PCEA) With or Without a Basal Infusion for Early Labor
• Study Start Date: May 2009
• Estimated Primary Completion Date: March 2010
• Estimated Study Completion Date: March 2010

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Analgesic duration [ Time Frame: request for analgesia ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes 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

Locations

United States, Massachusetts

Baystate Medical Center

Springfield, Massachusetts, United States, 01199

Sponsors and Collaborators

Neil Roy Connelly, MD

Investigators

• Principal Investigator: Neil Roy Connelly, MD; Baystate Medical Center

More Information

• Responsible Party: Neil Roy Connelly, MD, Anesthesiologist, Baystate Medical Center
• ClinicalTrials.gov Identifier: NCT00871442 History of Changes
• Other Study ID Numbers: IRB09-017
• First Posted: March 30, 2009
• Last Update Posted: November 18, 2015
• Last Verified: July 2009

Keywords provided by Neil Roy Connelly, MD, Baystate Medical Center:

PCEA; labor and delivery; pain; epidural; anesthesia; pregnant women

Additional relevant MeSH terms:

Labor Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Fentanyl; Anesthetics; Bupivacaine; Pharmaceutical Solutions; Central Nervous System Depressants; Physiological Effects of Drugs; Anesthetics, Local; Sensory System Agents; Peripheral Nervous System Agents; Analgesics, Opioid; Narcotics; Analgesics; Adjuvants, Anesthesia; Anesthetics, Intravenous; Anesthetics, General