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NCT03790124 · ClinicalTrials.gov registry record
Post-dural Puncture Headache: A Retrospective Study
A clinical trial, sponsored by Augusta University.
- Completed
- Registry status
- 50
- Enrollment target
NCT03790124: Completed study, sponsored by Augusta University.
NCT03790124 is a clinical trial that has completed, run by Augusta University. The registered enrollment target is 50 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03790124 has completed, sponsored by Augusta University.
- COMPLETED
- Registry status
- 50 participants
- Enrollment target
Study Summary
Neuraxial techniques are widely used in obstetric practice to provide analgesia and anesthesia. A common complication associated with neuraxial anesthesia is post-dural puncture headache (PDPH), resulting from unintentional or unintended puncture of the dura mater during insertion of an epidural needle. Incidence of PDPH after spinal anesthesia is very low due to the widespread use of non-cutting small diameter spinal needles. Incidence of "wet tap" during epidural injection has been reported to be 1.5%, with 52-85% of these patients developing PDPH. When an obstetric patient develops PDPH, institution of an effective treatment is necessary. Although PDPH tends to resolve spontaneously over a couple of weeks, it carries the risk of potential complications. PDPH interfere with the ability of the mother to take care of her baby, increases the risk of chronic headache and limits early ambulation, thereby increasing the risk of venous thrombosis and pulmonary embolism. As important as treating PDPH when it occurs is to prevent it when the dura is accidentally punctured during labor epidural placement. Multiple therapeutic strategies have been reported in the medical literature to prevent this outcome. Preventive measures range from conservative strategies to invasive procedures. Bedrest and hydration have been traditionally recommended to try to prevent PDPH when a wet tap occurs; however, no conclusive evidence supports their use. The use of oral and intravenous caffeine is insufficiently supported by clinical evidence. Epidural morphine and intravenous cosyntropin have been successfully used to prevent PDPH. Epidural injection of normal saline reduces the gradient for CSF leak. The use of saline has shown variable results in different studies. Although the results of some studies show insufficient evidence about its effectiveness, administration of epidural saline is a technique relatively devoid of significant adverse effects. The institutional protocol recommends
Primary Outcome
Number of patients who had wet tap during epidural placement who developed postdural puncture headache
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2019-02-01 |
| Est. Completion | 2019-03-30 |
What the finished NCT03790124 record still lists
NCT03790124 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT03790124 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03790124 about?
NCT03790124 is a clinical study titled "Post-dural Puncture Headache: A Retrospective Study". Neuraxial techniques are widely used in obstetric practice to provide analgesia and anesthesia. A common complication associated with neuraxial anesthesia is post-dural puncture headache (PDPH), resulting from unintentional or unintended puncture of the dura mater during insertion of an epidural nee...
What is the current status of trial NCT03790124?
This trial is currently completed. The enrollment target is 50 participants. The study started on 2019-02-01. Estimated completion is 2019-03-30.
Who is sponsoring clinical trial NCT03790124?
This trial is sponsored by Augusta University, which has 106 total clinical trials registered on ClinicalTrials.gov.
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