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

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02365909

Acronym

PDPH

Enrollment

Registered

2015-02-19

Start date

2015-06-29

Completion date

2016-08-30

Last updated

2017-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postdural Puncture Headache

Brief 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

DRUG0.5% bupivacaine

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

DRUGnormal saline

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
Headache verbal pain score	1 hour

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026