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

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.

Study Overview

• Status: Completed
• Conditions: Labor Pain; Labor Analgesia
• Intervention / Treatment: Procedure: Lumbar Epidural; Procedure: Dural Puncture Epidural

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: August 22, 2014
• First Submitted That Met QC Criteria: April 8, 2015
• First Posted (Estimate): April 9, 2015

Study Record Updates

• Last Update Posted (Estimate): August 17, 2016
• Last Update Submitted That Met QC Criteria: August 16, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: Pro00034219