Labor Pain Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 101 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Medical University of South Carolina | Charleston | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Medical University of South Carolina |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Compare time of onset of labor analgesia Dural Puncture vs Lumbar Puncture | two days post delivery | Yes | |
Secondary | Incidence of Side Effect | Incidence of maternal motor block, hypotension, pruritis, headache, patient satisfaction and fetal bradycardia. | two days post delivery | Yes |
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