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Completed

NCT Number: NCT02412969

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

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.

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Key information

Conditions

Labor Pain Labor Analgesia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lumbar epidural

Procedure

control group will receive lumbar puncture epidural

Dural puncture epidural

Procedure

intervention group will receive a dural puncture epidural

Primary outcomes

  1. Compare time of onset of labor analgesia Dural Puncture vs Lumbar Puncture

    Time frame: two days post delivery

Secondary outcomes

  1. Incidence of Side Effect

    Time frame: two days post delivery

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

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 9, 2015
Registry last updated
Aug 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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