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Clinical Trials/NCT02517931
NCT02517931
Withdrawn
Not Applicable

Sphenopalatine Ganglion Block for Treatment of Postdural Puncture Headache in the Emergency Department: A Prospective, Randomized, Double-Blind Placebo Controlled Study

University of Arkansas1 site in 1 countryJanuary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postdural Puncture Headache
Sponsor
University of Arkansas
Locations
1
Primary Endpoint
Pain level with Verbal Rating Scale
Status
Withdrawn
Last Updated
6 years ago

Overview

Brief Summary

This study evaluates sphenopalatine ganglion block (SPGB) for the treatment of postdural puncture headache (PDPH) in the emergency department (ED). Half of the patients will receive a true nerve block with lidocaine and bupivacaine. The other half will receive a placebo nerve block.

Detailed Description

Postdural puncture headaches (PDPH) are a common consequence of diagnostic lumbar puncture. The gold standard treatment for a PDPH is currently an autologous epidural blood patch (AEBP), which involves placing a needle into the epidural space of the spine and then injecting 20 ml of the patients own blood through the needle and into the epidural space to form a clot over the tear in the tissue layer that causes the headache. This is an invasive procedure that carries risks of pain, bleeding, infection, and in rare cases, neurological complications. We want to test the efficacy of using a less invasive procedure, called a sphenopalatine ganglion 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. We hope that the SPGB will reduce the number of PDPH patients that require an AEBP.

Registry
clinicaltrials.gov
Start Date
January 1, 2019
End Date
September 23, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Active postdural puncture headache within 7 days after diagnostic lumbar puncture
  • Age ≥ 18 years.
  • American Society of Anesthesiologists (ASA) physical status ≤ 3

Exclusion Criteria

  • Known coagulopathy
  • Known nasal septal deviation or abnormalities
  • Medical conditions contraindicated to lidocaine or bupivacaine

Outcomes

Primary Outcomes

Pain level with Verbal Rating Scale

Time Frame: 5 days

Patients will be asked to self rate their pain with 0 as no pain at all up to 10 being the worst pain imaginable.

Study Sites (1)

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