Impact of Dural Puncture Epidural Versus Traditional Lumbar Epidural on Onset of Labor Analgesia

Study Overview
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Brief Summary
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This study is to examine the onset of pain relief with two different methods of labor epidural. The traditional labor epidural involves the placement of numbing and anti-pain medicine in the epidural space which surrounds the spinal cord. In order to take effect, the medication has to cross a layer of tissue called the dura. In the current study, the same medications are placed in the epidural space after the dura is punctured with a fine needle. This research, will help evaluate whether this technique will result in earlier onset of pain relief.

Official Title
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Impact of Dural Puncture Epidural Versus Traditional Lumbar Epidural on Onset of Labor Analgesia

Conditions
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Labor Pain, Labor Analgesia

Intervention / Treatment
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* Procedure: Lumbar Epidural
* Procedure: Dural Puncture Epidural


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant patients in active painful labor ASA I and II parturients Women Ages 18+ to 40 Patients who have labor epidural as part of their labor plan will be recruited Exclusion Criteria: Patients admitted to the Labor and Delivery Suite who are committed to have a delivery with the current admission but who do not want a labor epidural Patients with the following: bleeding disorders, infection at the site of epidural placement, generalized sepsis, stenotic heart valve lesions, increased intracranial pressure, patients with hypovolemia, and patient refusal Parturients with chronic pain syndromes Patients on MAO inhibitors Patients with allergies to bupivacaine and fentanyl (and other amide local anesthetics) patients with substance abuse history will be excluded Non English-speaking patients will be excluded

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lumbar Epidural<br>Control group will have standard of care Lumbar Epidural | Procedure: Lumbar Epidural<br>* control group will receive lumbar puncture epidural<br>|
| Experimental: Dural Puncture Epidural<br>Will receive Dural Puncture Epidural | Procedure: Dural Puncture Epidural<br>* intervention group will receive a dural puncture epidural<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare time of onset of labor analgesia Dural Puncture vs Lumbar Puncture |  | two days post delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Side Effect | Incidence of maternal motor block, hypotension, pruritis, headache, patient satisfaction and fetal bradycardia. | two days post delivery |