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

Not Applicable

Completed

• Conditions: Labor Pain; Labor Analgesia
• Interventions: Procedure: Dural Puncture Epidural; Procedure: Lumbar Epidural

• Registration Number: NCT02412969
• Lead Sponsor: Medical University of South Carolina

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-22
• Study First Submitted QC: 2015-04-08
• Study First Posted: 2015-04-09
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-16
• Last Update Posted: 2016-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 101

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dural Puncture Epidural	Dural Puncture Epidural	Will receive Dural Puncture Epidural
Lumbar Epidural	Lumbar Epidural	Control group will have standard of care Lumbar Epidural

Primary Outcome Measures

Name	Time	Method
Compare time of onset of labor analgesia Dural Puncture vs Lumbar Puncture	two days post delivery

Secondary Outcome Measures

Name	Time	Method
Incidence of Side Effect	two days post delivery	Incidence of maternal motor block, hypotension, pruritis, headache, patient satisfaction and fetal bradycardia.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States