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

Postdural Puncture Headache Clinical Trial

— PDPH  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02365909
• Other study ID #: 203684
• Status: Terminated
• Phase: Early Phase 1
• First received: February 11, 2015
• Last updated: September 15, 2017
• Start date: June 29, 2015
• Est. completion date: August 30, 2016

Study information

• Verified date: September 2017
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: August 30, 2016
• Est. primary completion date: August 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Headache
• Post-Dural Puncture Headache
• Postdural Puncture Headache

Intervention

Drug:
• 0.5% bupivacaine
This group will receive 0.3 ml of 0.5% bupivacaine per nare, applied with the Tx360®
• normal saline
This group will receive 0.3 ml of normal saline per nare, applied with the Tx360®

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache verbal pain score		1 hour