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

University of Arkansas

Status and phase: Terminated; Early Phase 1

Conditions: Postdural Puncture Headache

Treatments: Drug: 0.5% bupivacaine; Drug: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02365909

203684

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Active postdural puncture headache within 7 days after neuraxial analgesia/anesthesia
• Age ≥ 18 years.
• ASA physical status ≤ 3

Exclusion Criteria

• Known coagulopathy
• Known nasal septal deviation or abnormalities
• Medical conditions contraindicated to bupivacaine or the nasal applicator (according to the product labeling)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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6 participants in 2 patient groups, including a placebo group

Acitve

Active Comparator group

Description:

This group will receive 0.3 ml of 0.5% bupivacaine per nare, applied with the Tx360®

Treatment:

Drug: 0.5% bupivacaine

Placebo

Placebo Comparator group

Description:

This group will receive 0.3 ml of normal saline per nare, applied with the Tx360®

Treatment:

Drug: normal saline