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Study stopped due to difficulty recruiting patients
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acitve | Active Comparator | This group will receive 0.3 ml of 0.5% bupivacaine per nare, applied with the Tx360® |
|
| Placebo | Placebo Comparator | This group will receive 0.3 ml of normal saline per nare, applied with the Tx360® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.5% bupivacaine | Drug | This group will receive 0.3 ml of 0.5% bupivacaine per nare, applied with the Tx360® |
|
| Measure | Description | Time Frame |
|---|---|---|
| Headache verbal pain score | 1 hour |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
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| ID | Term |
|---|---|
| D051299 | Post-Dural Puncture Headache |
| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| normal saline | Drug | This group will receive 0.3 ml of normal saline per nare, applied with the Tx360® |
|
| D009422 | Nervous System Diseases |
| D000588 |
| Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |