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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02412969
Enrollment
101
Registered
2015-04-09
Start date
2014-08-31
Completion date
2016-06-30
Last updated
2016-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Analgesia, Labor Pain

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.

Interventions

control group will receive lumbar puncture epidural

intervention group will receive a dural puncture epidural

Sponsors

Medical University of South Carolina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
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

Design outcomes

Primary

MeasureTime frame
Compare time of onset of labor analgesia Dural Puncture vs Lumbar Puncturetwo days post delivery

Secondary

MeasureTime frameDescription
Incidence of Side Effecttwo days post deliveryIncidence of maternal motor block, hypotension, pruritis, headache, patient satisfaction and fetal bradycardia.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026