SPG Blocks for Headaches

Sphenopalatine Ganglion Blocks for Headaches in the Emergency Department

This will be a single-center, open-label clinical trial comparing sphenopalatine ganglion blocks to standard intravenous therapy for patients who come to the emergency department for a headache.

Study Overview

• Status: Unknown
• Conditions: Headache
• Intervention / Treatment: Procedure: SPG Block; Drug: Standard IV Treatment

Detailed Description

Having outperformed other agents in head-to-head trials, intravenous (IV) dopamine antagonists, such as prochlorperazine or metoclopramide, are generally considered the 1st line treatment for headaches in the ED. However, despite the relative effectiveness of prochlorperazine, a substantial number of patients who present to the ED with a headache still have a moderate to severe headache 24 hours after discharge. Moreover, some patients may have difficult IV access, so it would be useful to employ a technique that could effectively treat headaches without the use of an IV line.

One therapy that has been suggested but not well-studied that might help treat headaches in the ED without the use of an IV line is the sphenopalatine ganglion (SPG) block via intranasal lidocaine. The sphenopalatine ganglion may play a role in the development of pain in primary headaches through the release of neuropeptides that activate or sensitize intracranial nociceptors. Several prior randomized trials have evaluated the use of intranasal lidocaine or bupivacaine vs placebo for patients with migraine headaches, and the results have been mixed.

Thus, the investigators propose a single-center, open-label, clinical trial to compare the efficacy of SPG blocks to standard IV therapy for headaches in the ED.

Adult patients who come to the ED for a suspected primary headache may be enrolled. Patients who are assigned to the standard IV therapy group will receive prochlorperazine 10 mg and diphenhydramine 50 mg.

Patients who are assigned to the SPG block group will undergo the following procedure. A cotton-tipped applicator soaked in 1% lidocaine will be placed in the nostril on the side of the headache. If the headache is bilateral, a cotton-tipped applicator will be inserted into each nostril. The cotton-tipped applicator(s) will be left in place for 15 minutes. If the patient has not had significant improvement upon removal of the cotton-tipped applicator the physician may order IV medication for the patient's headache ("rescue analgesia").

Just before the initiation of treatment, an initial visual analog scale (VAS) pain score will be obtained from the patient. The VAS pain score will be repeated 15 and 30 minutes after treatment. Additional data will be determined through chart review and telephone follow up with the patient 24-72 hours after discharge.

The primary outcome of the study will be the difference between groups in the fraction of patients with a 50% reduction in VAS pain score at 15 minutes. Secondarily, the investigators will compare groups with regards to their mean VAS pain scores as 15 and 30 minutes after the initiation of the first treatment, hospital length of stay, the need for rescue analgesic medications, complications (nose bleed, akathisia, etc.), and presence of persistent headache 24-72 hours after discharge on telephone follow up.

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33175
      • Recruiting
      • Kendall Regional Medical Center

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:

• Any patient at least 18 years old who presented to the ED with a suspected primary headache.

Exclusion Criteria:

• pregnant women
• prisoners
• meningeal signs
• fever
• any acute abnormality on neurologic exam
• allergy to one of study drugs
• on oral anticoagulant
• already received analgesic treatment in the ED

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SPG Block; Sphenopalatine ganglion block using cotton-tipped applicators soaked in 1% lidocaine will be performed.	Procedure: SPG Block; A cotton-tipped applicator soaked in 1% lidocaine will be inserted into the nostril on the side of the headache. If the headache is bilateral, two cotton-tipped applicators will be inserted. The cotton-tipped applicators will be left in place for 15 minutes.
Active Comparator: Standard Treatment; Intravenous prochlorperazine 10 mg plus diphenhydramine 50 mg.	Drug: Standard IV Treatment; Intravenous prochlorperazine 10 mg plus diphenhydramine 50 mg will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients with Substantial Pain Reduction at 15 minutes	The percentage of patients whose 100 mm visual analog scale pain score reduced by at least 50% from before treatment until 15 minutes after the start of treatment.	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mean Pain Score at 15 minutes	The difference in the mean 100 mm visual analog scale pain score from before treatment to 15 minutes after treatment, and the means for each group will be compared.	15 minutes
Change in Mean Pain Score at 30 minutes	The difference in the mean 100 mm visual analog scale pain score from before treatment to 15 minutes after treatment, and the means for each group will be compared.	30 minutes
Headache 24-72 hours later	Patients will be called by phone 24-72 hours after treatment in the ED to ask if they are having a headache (yes or no). The percentage of patients with a headache at that time will be compared between the groups.	24-72 hours
Hospital Length of Stay	The mean length of time the patient remains in the hospital will be compared between groups.	30 minutes to 1 week

Collaborators and Investigators

• Sponsor: Kendall Healthcare Group, Ltd.
• Collaborators: Nova Southeastern University

Publications and helpful links

General Publications

• Yarnitsky D, Goor-Aryeh I, Bajwa ZH, Ransil BI, Cutrer FM, Sottile A, Burstein R. 2003 Wolff Award: Possible parasympathetic contributions to peripheral and central sensitization during migraine. Headache. 2003 Jul-Aug;43(7):704-14. doi: 10.1046/j.1526-4610.2003.03127.x.
• Maizels M, Geiger AM. Intranasal lidocaine for migraine: a randomized trial and open-label follow-up. Headache. 1999 Sep;39(8):543-51. doi: 10.1046/j.1526-4610.1999.3908543.x. Erratum In: Headache 1999 Nov-Dec;39(10):764.
• Blanda M, Rench T, Gerson LW, Weigand JV. Intranasal lidocaine for the treatment of migraine headache: a randomized, controlled trial. Acad Emerg Med. 2001 Apr;8(4):337-42. doi: 10.1111/j.1553-2712.2001.tb02111.x.
• Mohammadkarimi N, Jafari M, Mellat A, Kazemi E, Shirali A. Evaluation of efficacy of intra-nasal lidocaine for headache relief in patients refer to emergency department. J Res Med Sci. 2014 Apr;19(4):331-5.
• Avcu N, Dogan NO, Pekdemir M, Yaka E, Yilmaz S, Alyesil C, Akalin LE. Intranasal Lidocaine in Acute Treatment of Migraine: A Randomized Controlled Trial. Ann Emerg Med. 2017 Jun;69(6):743-751. doi: 10.1016/j.annemergmed.2016.09.031. Epub 2016 Nov 23.
• Schaffer JT, Hunter BR, Ball KM, Weaver CS. Noninvasive sphenopalatine ganglion block for acute headache in the emergency department: a randomized placebo-controlled trial. Ann Emerg Med. 2015 May;65(5):503-10. doi: 10.1016/j.annemergmed.2014.12.012. Epub 2015 Jan 7.
• Maizels M, Scott B, Cohen W, Chen W. Intranasal lidocaine for treatment of migraine: a randomized, double-blind, controlled trial. JAMA. 1996 Jul 24-31;276(4):319-21.

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2020
• Primary Completion (Anticipated): May 30, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: February 3, 2020
• First Submitted That Met QC Criteria: February 3, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): September 3, 2020
• Last Update Submitted That Met QC Criteria: September 2, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: sphenopalatine ganglion block
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Headache
• Other Study ID Numbers: NSU IRB 2019-48

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: After completion of data analysis, the data will be available indefinitely.
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes