Sphenopalatine Ganglion Block for Postdural Puncture Headache in the Emergency Department

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Postdural Puncture Headache
• Intervention / Treatment: Procedure: Sphenopalatine Ganglion Block; Procedure: Placebo

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • 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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Sphenopalatine Ganglion Block; Subjects will be asked to blow out each nostril. They will then be laid supine with a small shoulder roll and intranasal phenylephrine 0.25% (RhinallⓇ) will be sprayed once into each nostril to preemptively minimize bleeding. Sphenopalatine ganglion block will be performed by inserting long cotton tipped applicators saturated in 2% viscous lidocaine into nostril until properly seated in the posterior nasopharynx. These will be left in place for 10 minutes and then 1 mililiter of 0.5% bupivacaine will be administered down the plastic hollow shaft of each applicator via an 18g angiocatheter. The applicators will remain in place for 10 more minutes and then be removed.	Procedure: Sphenopalatine Ganglion Block; Subjects will be asked to blow out each nostril. They will then be laid supine with a small shoulder roll and intranasal phenylephrine 0.25% (RhinallⓇ) will be sprayed once into each nostril to preemptively minimize bleeding. SPGB will be performed by inserting long cotton tipped applicators saturated in 2% viscous lidocaine into nostril until properly seated in the posterior nasopharynx. These will be left in place for 10 minutes and then 1mL of 0.5% bupivacaine will be administered down the plastic hollow shaft of each applicator via an 18g angiocatheter. The applicators will remain in place for 10 more minutes and then be removed.
PLACEBO_COMPARATOR: Placebo; Subjects will be asked to blow out each nostril. They will then be laid supine with a small shoulder roll and intranasal phenylephrine 0.25% (RhinallⓇ) will be sprayed once into each nostril to preemptively minimize bleeding. SPGB will be performed by inserting long cotton tipped applicators saturated in carboxymethylcellulose based lubricant (i.e. K-Y Jelly®) into nostril until properly seated in the posterior nasopharynx. These will be left in place for 10 minutes and then 1 mililiter of normal saline will be administered down the plastic hollow shaft of each applicator via an 18g angiocatheter. The applicators will remain in place for 10 more minutes and then be removed.	Procedure: Placebo; Subjects will be asked to blow out each nostril. They will then be laid supine with a small shoulder roll and intranasal phenylephrine 0.25% (RhinallⓇ) will be sprayed once into each nostril to preemptively minimize bleeding. SPGB will be performed by inserting long cotton tipped applicators saturated in carboxymethylcellulose based lubricant (i.e. K-Y Jelly®) into nostril until properly seated in the posterior nasopharynx. These will be left in place for 10 minutes and then 1 mililiter of normal saline will be administered down the plastic hollow shaft of each applicator via an 18g angiocatheter. The applicators will remain in place for 10 more minutes and then be removed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain level with Verbal Rating Scale	Patients will be asked to self rate their pain with 0 as no pain at all up to 10 being the worst pain imaginable.	5 days

Collaborators and Investigators

• Sponsor: University of Arkansas
• Investigators: Principal Investigator: Carly Eastin, MD, University of Arkansas

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ACTUAL): September 23, 2019
• Study Completion (ACTUAL): September 23, 2019

Study Registration Dates

• First Submitted: August 5, 2015
• First Submitted That Met QC Criteria: August 6, 2015
• First Posted (ESTIMATE): August 7, 2015

Study Record Updates

• Last Update Posted (ACTUAL): September 25, 2019
• Last Update Submitted That Met QC Criteria: September 23, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Disease Attributes; Headache Disorders; Headache Disorders, Secondary; Emergencies; Headache; Post-Dural Puncture Headache
• Other Study ID Numbers: 204502

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No