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

Medical University of South Carolina (MUSC) logo

Medical University of South Carolina (MUSC)

Status

Completed

Conditions

Labor Pain
Labor Analgesia

Treatments

Procedure: Lumbar Epidural
Procedure: Dural Puncture Epidural

Study type

Interventional

Funder types

Other

Identifiers

NCT02412969
Pro00034219

Details and patient eligibility

About

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.

Enrollment

101 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

101 participants in 2 patient groups

Lumbar Epidural
Active Comparator group
Description:
Control group will have standard of care Lumbar Epidural
Treatment:
Procedure: Lumbar Epidural
Dural Puncture Epidural
Experimental group
Description:
Will receive Dural Puncture Epidural
Treatment:
Procedure: Dural Puncture Epidural

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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