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NCT02365909 · ClinicalTrials.gov registry record · Early Phase 1
Study Evaluating Sphenopalatine Ganglion Block (SPGB) for Treatment of Postdural Puncture Headache (PDPH)
A Early Phase 1 study, sponsored by University of Arkansas.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 6
- Enrollment target
NCT02365909 is a Early Phase 1 study that was terminated before completion, run by University of Arkansas. The registered enrollment target is 6 participants.
The verdict
NCT02365909, a Early Phase 1 study, was terminated before completion, sponsored by University of Arkansas.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
Postdural puncture headaches (PDPH) are a consequence of spinal and epidural anesthesia in approximately 1% of cases when performed in obstetric patients. The gold standard treatment for a PDPH is currently an epidural blood patch (EBP), which involves placing a needle back into the epidural space of the neuraxium and then injecting 20 ml of the patient's own blood through the needle and into the epidural space to form a clot over the insult in the tissue layer that causes the headaches. The investigators want to test the efficacy of using a less invasive procedure, called a sphenopalatine block (SPGB), for treatment of PDPH. SPGB has been used for many years in the treatment of migraines and cluster headaches, and there are several case reports of its use to successfully treat PDPH as well. SPGB simply involves applying a local anesthetic to the mucosa in the back of each nostril to numb the nerves that cause the headache. The investigators hope that the SPGB will reduce the number of PDPH patients that require and EBP.
Interventions
- DRUG normal saline
- DRUG 0.5% bupivacaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2015-06-29 |
| Est. Completion | 2016-08-30 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02365909
The ClinicalTrials.gov registry entry for NCT02365909 describes a study currently listed as terminated, categorized as Early Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arkansas, which has 318 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which normal saline is the first listed.
NCT02365909 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02365909 about?
NCT02365909 is a clinical study titled "Study Evaluating Sphenopalatine Ganglion Block (SPGB) for Treatment of Postdural Puncture Headache (PDPH)". Postdural puncture headaches (PDPH) are a consequence of spinal and epidural anesthesia in approximately 1% of cases when performed in obstetric patients. The gold standard treatment for a PDPH is currently an epidural blood patch (EBP), which involves placing a needle back into the epidural space o...
What is the current status of trial NCT02365909?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 6 participants. The study started on 2015-06-29. Estimated completion is 2016-08-30.
What interventions are being tested in trial NCT02365909?
The interventions under investigation include: normal saline (DRUG), 0.5% bupivacaine (DRUG).
Who is sponsoring clinical trial NCT02365909?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
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