Sphenopalatine Ganglion Blockade in Migraine

NCT05210192 | Unknown Phase 3 FDA Drug

• 1 other identifier: 303
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Episodic Migraine

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

placebo arm

PLACEBO COMPARATOR

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

lidocaine arm

ACTIVE COMPARATOR

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

Interventions

Lidocaine Hydrochloride 1% Solution for Injection_#2 DRUG

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.

lidocaine arm

Placebo DRUG

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.

placebo arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

MeSH Terms

Interventions

Lidocaine; Solutions

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pharmaceutical Preparations

Central Study Contacts

gökçe zeytin demiral

CONTACT

05547250675; gokce_zeytin@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind placebo-controlled study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor Lecturer

Model Details: 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 Record Dates

• First Submitted: December 3, 2021
• First Posted: January 27, 2022
• Study Start: April 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: January 1, 2023
• Last Updated: January 27, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share