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It was decided that this study was not feasible at our institution.
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This study explores the potential for a more rapid onset of pain relief when drug administration is performed through the epidural needle, a technique of epidural loading that provides a rapid and reliable level of labor analgesia without the disadvantages of a combined spinal-epidural, and could add a valuable new tool to anesthesiologists.
This study explores the potential for a more rapid onset of pain relief when drug administration is performed through the epidural needle, a technique of epidural loading that provides a rapid and reliable level of labor analgesia without the disadvantages of a combined spinal-epidural, and could add a valuable new tool to anesthesiologists. Investigators propose to conduct a single blinded, randomized controlled trial to determine if a difference exists in the speed of onset and spread of labor analgesia between patients receiving an epidural loading dose through the epidural needle or catheter.
Group 1 (Epidural Catheter Administration) participants will receive the 10 mL epidural loading dose in 5 mL increments via the epidural catheter following catheter placement (current standard practice).
Group 2 (Epidural Needle Administration ) participants will receive the 10 mL epidural loading dose in 5 mL increments via the epidural needle prior to catheter placement (experimental group).
Various parameters will be measured in the time after drug administration to evaluate blood pressure, heart rate, and fetal heart rate. Following delivery, the total anesthetic dose, total number of doses demanded, total number and dosage of rescue doses, and overall patient satisfaction will be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epidural Catheter Administration | Active Comparator | Participants will receive the 10 mL epidural loading dose in 5 mL increments via the epidural catheter following catheter placement. (Current standard practice) Epidural loading dose via epidural catheter. |
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| Epidural Needle Administration | Experimental | Participants will receive the 10 mL epidural loading dose in 5 mL increments via the epidural needle prior to catheter placement. Epidural loading dose via epidural needle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidural loading dose | Procedure | Labor epidural analgesia loading dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean VAS pain score | Mean VAS pain score will be determined 20 minutes following epidural loading, including assessments at 5, 10, 15, and 20 minutes. | 20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Analgesic level | Analgesic level assessed by pinprick at 10, 15 and 20 minutes following loading | 10, 15, and 20 minutes |
| Maternal Blood Pressure | Change in maternal blood pressure loading |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Goran Ristev, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
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| Epidural catheter | Device | Epidural loading dose via epidural catheter |
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| Epidural needle | Device | Epidural loading dose via epidural needle |
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| Baseline and 20 minutes |
| Fetal Heart Rate | Change in fetal heart rate over 20 minutes following loading | Baseline and 20 minutes |
| Rescue Bolus Count | Number of rescue bolus doses will be counted | During Labor |
| Analgesia Satisfaction | Overall patient satisfaction with analgesia following delivery via questionnaire | During labor |
| Intravascular catheter placement | Incidence of intravascular catheter placement | During labor |
| Total anesthetic dose required | The total anesthetic dose during labor will be calculated | During Labor |
| Maternal Heart Rate | Change in maternal heart rate | Baseline and 20 minutes |