Sphenopalatine Ganglion Nerve BlockPhase 1NCT05707754
Sphenopalatine Ganglion Block Study
A Phase 1 study testing Bupivacaine and angiocatheter in people with Sphenopalatine Ganglion Nerve Block, run by Montefiore Medical Center at 1 site in United States.
Trial summary
The goal of this clinical trial is to compare the administration and dosage of bupivacaine for sphenopalatine ganglion (SPG) nerve block. The main question[s] it aims to answer are: Does a high dose (3ml) give more relief than a low dose (1ml)? Does bilateral administration give more relief than unilateral?… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sphenopalatine Ganglion Nerve Block
- What is being tested?
- Bupivacaine and angiocatheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2023to 30 Aug 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Present to ED for management of headache
- Headache is moderate or severe in intensity
Who cannot join
- Allergy to bupivacaine
- Nasal or sinus surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: A Randomized Trial of a Sphenopalatine Ganglion Block With Bupivacaine for Acute Headache
The goal of this clinical trial is to compare the administration and dosage of bupivacaine for sphenopalatine ganglion (SPG) nerve block. The main question[s] it aims to answer are:
- Does a high dose (3ml) give more relief than a low dose (1ml)?
- Does bilateral administration give more relief than unilateral? Participants with headaches will be asked to lie down and have SPG block performed.
Researchers will compare dosage and administration to see how symptoms are reduced.
- Conditions
- Sphenopalatine Ganglion Nerve Block
- Being tested
- Bupivacaine, angiocatheter
- Keywords
- Sphenopalatine ganglion nerve, Peripheral nerve block, Headache, Migraine
- Medical subject headings
- Headache, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Topically applied to sphenopalatine ganglion
angiocatheterDevice
Introduced into nose to reach sphenopalatine ganglion nerve
| Study group | Role | What they receive |
|---|---|---|
| High dose with unilateral administration | Active comparator | High dose (3ml) with unilateral administration of bupivacaine Receives: Drug: Bupivacaine; Device: angiocatheter |
| High dose with bilateral administration | Active comparator | High dose (3ml) with bilateral administration of bupivacaine Receives: Drug: Bupivacaine; Device: angiocatheter |
| Low dose with unilateral administration | Active comparator | Low dose (1ml) with unilateral administration of bupivacaine Receives: Drug: Bupivacaine; Device: angiocatheter |
| Low dose with bilateral administration | Active comparator | Low dose (1ml) with bilateral administration of bupivacaine Receives: Drug: Bupivacaine; Device: angiocatheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants demonstrating sustained headache relief
A standard ordinal headache intensity scale will be used for participants to describe their headache as either "severe", "moderate", "mild", or "none". The number of participants who are able to achieve a headache level of "mild" or "none" in the ED within 30 minutes of procedure/medication administration and without requiring additional analgesic medication, and not relapsing to a headache level worse than "mild" during the 48 hours after medication administration, will be determined
Measured: 48 hours
Secondary outcomes (1)
Number of participants demonstrating satisfaction with the procedure/medication
Satisfaction with the procedure/medication as evidenced by the number of participants who provide an affirmative response to the question "Do you want to receive the same procedure/medication the next time you come to the ER with migraine?"
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start6 Mar 2023
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sphenopalatine Ganglion Nerve BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Friedman, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05707754
- Sponsor's protocol ID
- 2022-14616
- Status last verified
- Oct 2024
- First submitted
- 22 Jan 2023
- Last updated
- 8 Oct 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of a Sphenopalatine Ganglion Block With Bupivacaine for Acute Headache
- ClinicalTrials.gov ID
- NCT05707754
- Acronym / sponsor ID
- 2022-14616
- Conditions
- Sphenopalatine Ganglion Nerve Block
- Keywords
- Sphenopalatine ganglion nerve, Peripheral nerve block, Headache, Migraine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 1 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare the administration and dosage of bupivacaine for sphenopalatine ganglion (SPG) nerve block. The main question[s] it aims to answer are:
- Does a high dose (3ml) give more relief than a low dose (1ml)?
- Does bilateral administration give more relief than unilateral? Participants with headaches will be asked to lie down and have SPG block performed.
Researchers will compare dosage and administration to see how symptoms are reduced.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High dose with unilateral administration | Active comparator | Drug: Bupivacaine, Device: angiocatheterHigh dose (3ml) with unilateral administration of bupivacaine |
| High dose with bilateral administration | Active comparator | Drug: Bupivacaine, Device: angiocatheterHigh dose (3ml) with bilateral administration of bupivacaine |
| Low dose with unilateral administration | Active comparator | Drug: Bupivacaine, Device: angiocatheterLow dose (1ml) with unilateral administration of bupivacaine |
| Low dose with bilateral administration | Active comparator | Drug: Bupivacaine, Device: angiocatheterLow dose (1ml) with bilateral administration of bupivacaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Present to ED for management of headache
- Headache is moderate or severe in intensity
Key exclusion criteria (2 listed)
- Allergy to bupivacaine
- Nasal or sinus surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BupivacaineTopically applied to sphenopalatine ganglion | Drug | High dose with bilateral administration, High dose with unilateral administration, Low dose with bilateral administration, Low dose with unilateral administration |
| angiocatheterIntroduced into nose to reach sphenopalatine ganglion nerve | Device | High dose with bilateral administration, High dose with unilateral administration, Low dose with bilateral administration, Low dose with unilateral administration |
Primary outcome
Number of participants demonstrating sustained headache relief
Time frame: 48 hours
A standard ordinal headache intensity scale will be used for participants to describe their headache as either "severe", "moderate", "mild", or "none". The number of participants who are able to achieve a headache level of "mild" or "none" in the ED within 30 minutes of procedure/medication administration and without requiring additional analgesic medication, and not relapsing to a headache level worse than "mild" during the 48 hours after medication administration, will be determined
1 secondary outcome
Number of participants demonstrating satisfaction with the procedure/medication
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Friedman, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bupivacaine and angiocatheter in people with Sphenopalatine Ganglion Nerve Block, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants demonstrating sustained headache relief (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.