Sphenopalatine Ganglion Blocks RCT

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2021-07-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

RCT of Sphenopalatine Ganglion (SPG) Blocks using anesthetics vs. placebo for migraine.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effect of Ganglion Sphenopalatine Block Versus Placebo on Persistent Headache Following COVID-19 Infection

NCT04636034

Headache Covid19 Sphenopalatine Ganglion Block +1 more

TERMINATED PHASE3

Greater Occipital Nerve Block for Migraine Prophylaxis

NCT00915473

Migraine Headache

COMPLETED PHASE4

Sphenopalatine Ganglion Block Study

NCT05707754

Sphenopalatine Ganglion Nerve Block

COMPLETED PHASE1

The Effect of Ganglion Sphenopalatine Block (GSP-block) Versus Placebo on Postdural Puncture Headache

NCT03652714

Postdural Puncture Headache Sphenopalatine Ganglion Block

COMPLETED PHASE3

Efficacy of Nerve Blocks for Episodic Migraine

NCT05734625

Episodic Migraine

RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Chronic Migraine is a brain disorder with high prevalence. It is the 7th leading cause of disability worldwide according the WHO.

SPG block is a treatment for migraine that has been used for two decades. It can be done by needle injection of anesthetic to the region of the SPG. However, there are now multiple catheter devices that can be used to non-invasively administer anesthetic topically through the nasal cavity to the region of the SPG where the anesthetic is then absorbed through thin membranes covering the SPG.

Various anesthetic agents have been studied however currently, to our knowledge, there is no head to head comparison of the various anesthetics used. Studies of SPG blocks in the setting of chronic migraine are few as compared to the use of SPG as acute treatment for migraine.

With the use of an RCT, we aim to determine the overall efficacy of SPG blocks used at longer intervals than have been studied in the past as compared to placebo, as well as to examine the relative efficacy of the anesthetics used most commonly and studied for SPG blocks.

We will be using an FDA cleared device, the Sphenocath which was developed and registered with the FDA for this specific population and purpose. The study intervention is the standard practice in the UCSF Headache Center to perform SPG blocks for our patients with chronic migraine. The frequency we use in clinical practice and that we plan to study is less often than in previous studies of this intervention in this population.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Migraine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized placebo controlled study

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double blind study

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lidocaine

Participants will receive SPG blocks with lidocaine.

Group Type EXPERIMENTAL

Lidocaine

Intervention Type DRUG

Nasal application using the Sphenocath device- cleared by FDA

Bupivacaine

Participants will receive SPG blocks with bupivacaine

Group Type EXPERIMENTAL

Bupivacaine

Intervention Type DRUG

Nasal application using the Sphenocath device- cleared by FDA

Ropivacaine

Participants will receive SPG blocks with ropivacaine

Group Type EXPERIMENTAL

Ropivacaine

Intervention Type DRUG

Nasal application using the Sphenocath device- cleared by FDA

Placebo (saline)

Participants will receive SPG blocks with placebo (saline)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo Saline using the Sphenocath device- cleared by FDA

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lidocaine

Nasal application using the Sphenocath device- cleared by FDA

Intervention Type DRUG

Bupivacaine

Nasal application using the Sphenocath device- cleared by FDA

Intervention Type DRUG

Ropivacaine

Nasal application using the Sphenocath device- cleared by FDA

Intervention Type DRUG

Placebo

Placebo Saline using the Sphenocath device- cleared by FDA

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Placebo Saline

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age 18 years or more at time of consent
2. Current patients in the UCSF Headache Center eligible to receive SPG blocks for migraine and would otherwise receive treatment clinically
3. Ability to provide consent for the research study

Exclusion Criteria

1. Pregnant or breast feeding within 4 weeks of enrollment
2. Inability to communicate with the study team
3. Patients who cannot read and understand English
4. Deemed unsuitable for enrollment in study by the investigator
5. Allergy to local anesthetics or saline

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No