Impact of Dural Puncture Epidural Versus Traditional Lumbar Epidural on Onset of Labor Analgesia
1 other identifier
interventional
101
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 22, 2014
CompletedFirst Posted
Study publicly available on registry
April 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedAugust 17, 2016
August 1, 2016
1.8 years
August 22, 2014
August 16, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Compare time of onset of labor analgesia Dural Puncture vs Lumbar Puncture
two days post delivery
Secondary Outcomes (1)
Incidence of Side Effect
two days post delivery
Study Arms (2)
Lumbar Epidural
ACTIVE COMPARATORControl group will have standard of care Lumbar Epidural
Dural Puncture Epidural
EXPERIMENTALWill receive Dural Puncture Epidural
Interventions
intervention group will receive a dural puncture epidural
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Director of OB Anesthesia
Study Record Dates
First Submitted
August 22, 2014
First Posted
April 9, 2015
Study Start
August 1, 2014
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
August 17, 2016
Record last verified: 2016-08