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The purpose of this study is to evaluate whether changing the volume and concentration of a medication affects the quality of pain relief and the side effects associated with labor epidural analgesia.
This is a randomized, single blinded trial comparing epidural pain relief for labor when medications are delivered in one of two volumes/concentrations. Patients in each arm of the study will receive the same dose of medication, but one will be half as concentrated and twice the volume. The outcome will be the number of supplemental doses of medication that patients receive during labor via their patient-controlled analgesia button.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High volume low concentration | Active Comparator | combination product: 0.0625% bupivacaine with 2 mcg fentanyl delivered in 12 ml bolused every 40 minutes |
|
| Low concentration high volume | Experimental | combination product: 0.125% bupivacaine with 4 mcg fentanyl delivered in 6 ml bolused every 40 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| administration of bupivacaine 7.5 mg and fentanyl 24 mcg every 40 minutes | Drug | Dose of medication delivered using a programmed intermittent epidural bolus |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient controlled boluses received | The number of patient-controlled boluses received by the patient by pressing the patient-controlled analgesia (PCA) button for additional pain relief | The duration of labor until delivery of the neonate |
| Measure | Description | Time Frame |
|---|---|---|
| Patient controlled boluses requests | The number of patient controlled boluses requested by pressing the PCA button for additional pain relief | The duration of labor until delivery of the neonate |
| Physician administered epidural bolus |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Amis | Contact | (617) 667-1861 | eamis@bidmc.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Philip Hess, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
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| ID | Term |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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The number of times that a physician supplies additional medication for the control of pain
| The duration of labor until delivery of the neonate |