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

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

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.

Study Overview

• Status: Terminated
• Conditions: Postdural Puncture Headache
• Intervention / Treatment: Drug: 0.5% bupivacaine; Drug: normal saline

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Acitve; This group will receive 0.3 ml of 0.5% bupivacaine per nare, applied with the Tx360®	Drug: 0.5% bupivacaine; This group will receive 0.3 ml of 0.5% bupivacaine per nare, applied with the Tx360®
Placebo Comparator: Placebo; This group will receive 0.3 ml of normal saline 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®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Headache verbal pain score	1 hour

Collaborators and Investigators

• Sponsor: University of Arkansas

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2015
• Primary Completion (Actual): August 30, 2016
• Study Completion (Actual): August 30, 2016

Study Registration Dates

• First Submitted: February 11, 2015
• First Submitted That Met QC Criteria: February 11, 2015
• First Posted (Estimate): February 19, 2015

Study Record Updates

• Last Update Posted (Actual): September 18, 2017
• Last Update Submitted That Met QC Criteria: September 15, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders; Headache Disorders, Secondary; Headache; Post-Dural Puncture Headache; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 203684