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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-06-30

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.

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Detailed Description

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Conditions

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Labor Pain Labor Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lumbar Epidural

Control group will have standard of care Lumbar Epidural

Group Type ACTIVE_COMPARATOR

Lumbar Epidural

Intervention Type PROCEDURE

control group will receive lumbar puncture epidural

Dural Puncture Epidural

Will receive Dural Puncture Epidural

Group Type EXPERIMENTAL

Dural Puncture Epidural

Intervention Type PROCEDURE

intervention group will receive a dural puncture epidural

Interventions

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Lumbar Epidural

control group will receive lumbar puncture epidural

Intervention Type PROCEDURE

Dural Puncture Epidural

intervention group will receive a dural puncture epidural

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes