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

• Sponsor: Medical University of South Carolina (Other)
• Overall Status: Completed
• CT.gov ID: NCT02412969
• Collaborator: (none)
• Enrollment: 101
• Location: 1
• Arms: 2
• Duration (Months): 22
• Patients Per Site Per Month: 4.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Labor Pain; Labor Analgesia	Procedure: Lumbar Epidural; Procedure: Dural Puncture Epidural	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 101 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Impact of Dural Puncture Epidural Versus Traditional Lumbar Epidural on Onset of Labor Analgesia
• Study Start Date: Aug 1, 2014
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Compare time of onset of labor analgesia Dural Puncture vs Lumbar Puncture [two days post delivery]

Secondary Outcome Measures

1. Incidence of Side Effect [two days post delivery]

   Incidence of maternal motor block, hypotension, pruritis, headache, patient satisfaction and fetal bradycardia.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of South Carolina	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

• Medical University of South Carolina

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Latha Hebbar, Professor and Director of OB Anesthesia, Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT02412969
• Other Study ID Numbers: Pro00034219
• First Posted: Apr 9, 2015
• Last Update Posted: Aug 17, 2016
• Last Verified: Aug 1, 2016

• Additional relevant MeSH terms: Labor Pain

Study Results

No Results Posted as of Aug 17, 2016