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

Labor Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02412969
• Other study ID #: Pro00034219
• Status: Completed
• Phase: N/A
• First received: August 22, 2014
• Last updated: August 16, 2016
• Start date: August 2014
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Labor Analgesia
• Labor Pain

Intervention

Procedure:
• Lumbar Epidural
control group will receive lumbar puncture epidural
• Dural Puncture Epidural
intervention group will receive a dural puncture epidural

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare time of onset of labor analgesia Dural Puncture vs Lumbar Puncture		two days post delivery	Yes
Secondary	Incidence of Side Effect	Incidence of maternal motor block, hypotension, pruritis, headache, patient satisfaction and fetal bradycardia.	two days post delivery	Yes