Parturient Controlled Epidural Analgesia (PCEA) With or Without a Basal Infusion for Early Labor
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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 |
- 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:
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:
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 |
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| United States, Massachusetts | |
| Baystate Medical Center | |
| Springfield, Massachusetts, United States, 01199 | |
| 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 May 22, 2013