NCT02365909

Study Evaluating Sphenopalatine Ganglion Block (SPGB) for Treatment of Postdural Puncture Headache (PDPH)

A Prospective Randomized Double-Blind Placebo Controlled Study Evaluating Sphenopalatine Ganglion Block (SPGB) for Treatment of Postdural Puncture Headache (PDPH)

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Postdural Puncture Headache

Interventions

Type	Name	Description
DRUG	0.5% bupivacaine	This group will receive 0.3 ml of 0.5% bupivacaine per nare, applied with the Tx360®
DRUG	normal saline	This group will receive 0.3 ml of normal saline per nare, applied with the Tx360®

Timeline

• Start date: 2015-06-29
• Primary completion: 2016-08-30
• Completion: 2016-08-30
• First posted: 2015-02-19
• Last updated: 2017-09-18

Locations

1 site across 1 country: United States