NCT02365909: PDPH

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

Terminated EARLY_PHASE1 Last updated 18 September 2017

What this trial tests

EARLY_PHASE1 trial testing 0.5% bupivacaine in Postdural Puncture Headache in 6 participants. Terminated before completion.

Timeline

29 June 2015

Primary endpoint
30 August 2016

30 August 2016

Quick facts

Lead sponsor	University of Arkansas
Phase	EARLY_PHASE1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	6
Start date	29 June 2015
Primary completion	30 August 2016
Estimated completion	30 August 2016
Sites	1 location across United States

Drugs / interventions tested

• 0.5% bupivacaine — full drug profile →
• normal saline

Conditions studied

• Postdural Puncture Headache — all drugs for Postdural Puncture Headache →

Sponsor

University of Arkansas

Who can join

18 and older, any sex, with Postdural Puncture Headache. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.