Sphenopalatine Ganglion Blockade in Migraine

Sphenopalatine Ganglion Blockade With Local Analgesic in Episodic Migraine

Migraine is a fairly common disease that is a leading cause of disability worldwide. 15% of the general population suffer from migraine headaches. Although there are currently many options for the treatment of acute migraine, these treatment options, such as acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDS), triptans, combinations analgesics and antiemetics, have insufficient efficacy and significant side effects. Therefore, there is a need for new treatment modalities in migraine. Sphenopalatine ganglion (SPG) block is gaining interest as an effective treatment for migraine, other headaches and facial pain syndromes.

In our study, we aimed to block the Sphenopalatine ganglion with a local anesthetic drug and compare it with the placebo control group.

Study Overview

• Status: Not yet recruiting
• Conditions: Episodic Migraine
• Intervention / Treatment: Drug: Placebo; Drug: Lidocaine Hydrochloride 1% Solution for Injection_#2

Detailed Description

Between 1 May and 1 December 2021, 50 patients aged 18-50 years, who were diagnosed with episodic migraine according to ICD III criteria, who applied to the headache outpatient clinic of Afyonkarahisar Health Sciences University Medical Faculty Hospital, are planned to be included in the study. Patients with similar age, gender and disease duration will be randomly divided into 2 groups using the closed envelope method. Demographic information of the patients, chronic disease history, medications used, and duration of disease will be questioned. Before the treatment, the frequency of pain, the number of attacks, the severity of pain (VAS), and the duration of pain will be questioned. VAS (visual analog scale) is a scale that evaluates the severity of pain. This scale consists of numerical values between 0 and 10. 0 is considered no pain, and 10 is considered the most severe pain. Routine attack treatment of the patients will continue. Injection into the sphenopalatine ganglion of the patients in both groups will be made by entering the arcus zygomaticum and oriented at a 45 degree angle towards the opposite tooth. Injections will be made with a dental injector. The first group will be injected with 4ml of 1% lidocaine, and the second group will be injected with 4ml of 0.9% saline. Injections will be repeated weekly for the first 4 weeks, then monthly. At the end of the 1st and 3rd months of the treatment, the patients will be evaluated in the routine outpatient clinic control, and the two groups will be compared statistically by questioning the frequency of pain, the number of attacks, the severity of pain (VAS), and the duration of pain.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: gökçe zeytin demiral; Phone Number: 05547250675; Email: gokce_zeytin@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Having a diagnosis of episodic migraine (according to ICD-III)
• Receiving any prophylaxis treatment in the last 3 months,

Exclusion Criteria:

• Being pregnant and lactating
• Neurological and psychiatric conditions (
• Contraindications to the use of local anesthetics
• Other chronic painful conditions,
• Having a history of malignancy

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
Placebo Comparator: placebo arm; Injection into the sphenopalatine ganglion of the patients in both groups will be made by entering the arcus zygomaticum and oriented at a 45 degree angle towards the opposite tooth. Injections will be made with a dental injector. Placebo group will be injected with 4ml of 0.9% saline. Injections will be repeated weekly for the first 4 weeks, then monthly. At the end of the 1st and 3rd months of the treatment, the patients will be evaluated in the routine outpatient clinic control, and the two groups will be compared statistically by questioning the frequency of pain, the number of attacks, the severity of pain (VAS), and the duration of pain.	Drug: Placebo; Injection into the sphenopalatine ganglion of the patients in both groups will be made by entering the arcus zygomaticum and oriented at a 45 degree angle towards the opposite tooth. Injections will be made with a dental injector. The second group will be injected with 4ml of 0.9% saline. Injections will be repeated weekly for the first 4 weeks, then monthly. At the end of the 1st and 3rd months of the treatment, the patients will be evaluated in the routine outpatient clinic control, and the two groups will be compared statistically by questioning the frequency of pain, the number of attacks, the severity of pain (VAS), and the duration of pain.
Active Comparator: lidocaine arm; Injection into the sphenopalatine ganglion of the patients in both groups will be made by entering the arcus zygomaticum and oriented at a 45 degree angle towards the opposite tooth. Injections will be made with a dental injector. Lidocaine group will be injected with 4ml of 0.1%Lidocaine. Injections will be repeated weekly for the first 4 weeks, then monthly. At the end of the 1st and 3rd months of the treatment, the patients will be evaluated in the routine outpatient clinic control, and the two groups will be compared statistically by questioning the frequency of pain, the number of attacks, the severity of pain (VAS), and the duration of pain.	Drug: Lidocaine Hydrochloride 1% Solution for Injection_#2; Injection into the sphenopalatine ganglion of the patients in both groups will be made by entering the arcus zygomaticum and oriented at a 45 degree angle towards the opposite tooth. Injections will be made with a dental injector. The first group will be injected with 4ml of 1% lidocaine. Injections will be repeated weekly for the first 4 weeks, then monthly. At the end of the 1st and 3rd months of the treatment, the patients will be evaluated in the routine outpatient clinic control, and the two groups will be compared statistically by questioning the frequency of pain, the number of attacks, the severity of pain (VAS), and the duration of pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency and Pain Level of Migraines Post-Treatment	The frequency and pain level of subjects' migraines will be assessed upon the conclusion of the study through surveying and comparing to previous survey data.	3-6 months after start

Collaborators and Investigators

• Sponsor: Afyonkarahisar Health Sciences University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2022
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: December 3, 2021
• First Submitted That Met QC Criteria: January 26, 2022
• First Posted (Actual): January 27, 2022

Study Record Updates

• Last Update Posted (Actual): January 27, 2022
• Last Update Submitted That Met QC Criteria: January 26, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 303 (Klein Buendel, Inc.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

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