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

NCT00871442 | Withdrawn Phase 3

• 1 other identifier: IRB09-017
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Analgesic duration

  request for analgesia

Study Arms (2)

No Basal Infusion

ACTIVE COMPARATOR

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; Drug: PCEA solution (bupivacaine and fentanyl)

Basal Infusion

ACTIVE COMPARATOR

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; Drug: PCEA solution (bupivacaine and fentanyl)

Interventions

No Basal Infusion OTHER

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

Also known as: epidural infusion, bupivicaine, patient controlled epidural anesthesia (PCEA), PCEA pump settings

No Basal Infusion

Basal infusion OTHER

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

Also known as: epidural infusion, bupivicaine, patient controlled epidural anesthesia (PCEA), PCEA pump settings

Basal Infusion

PCEA solution (bupivacaine and fentanyl) DRUG

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

Basal Infusion; No Basal Infusion

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neil Roy Connelly, MD: lead

Study Sites (1)

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

MeSH Terms

Conditions

Labor Pain; Pain

Interventions

Bupivacaine; Fentanyl

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Neil Roy Connelly, MD

  Baystate Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: March 27, 2009
• First Posted: March 30, 2009
• Study Start: May 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: November 18, 2015

Record last verified: 2009-07

Locations

US (1)