Subarachnoid HemorrhagePhase 1NCT04331938
Efficacy of Percutaneous SPG Block in Aneurysmal SAH
A Phase 1 study testing Regional anesthetic SPG block-bilateral in people with Subarachnoid Hemorrhage and Headache, run by Mayo Clinic at 1 site in United States.
Trial summary
Researchers are trying to develop alternative means to help patients with headache pain secondary to aneurysmal subarachnoid hemorrhage (bleeding about the brain). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage, Headache
- What is being tested?
- Regional anesthetic SPG block-bilateral
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2020to 8 Apr 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and older
- Aneurysmal SAH in anterior/middle cerebral compartment
- Aneurysm must be secured endovascular with coiling
- The patient or patient's surrogate should be able to give informed consent and understand the risks of this study
- Pain NRS ≥ 5/10 in severity
Who cannot join
- Non aneurysmal, traumatic SAH
- Posterior fossa aneurysm ruptures
- Pregnancy
- Transcranial Doppler velocities suggestive of or approaching vasospasm
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: The Efficacy of Landmark-guided Percutaneous Sphenopalatine Ganglion Block on Self-reported Headache Pain Secondary to Aneurysmal Subarachnoid Hemorrhage: A Feasibility Study
Researchers are trying to develop alternative means to help patients with headache pain secondary to aneurysmal subarachnoid hemorrhage (bleeding about the brain).
Read the detailed description
This study is an open label, feasibility study that will consist of fifteen patients. This study will enroll only patients who have aneurysmal SAH that are secured by endovascular coiling. When a patient notes a severe headache which requires medical intervention on at least day 3 of the hospital admission, they will be asked if they would like to participate in an open label trial to use a bilateral SSPGB in addition to traditional medical management per unit protocol. The risks and benefits of the procedure will be explained to the patient. The patient will then either agree or disagree. If the patient disagrees, they will not be enrolled in the study. If the patient agrees, they will sign an informed consent and will be enrolled. Inclusion and exclusion criteria will be reviewed before enrolling a patient. The patients will first rate their pain from 0-10 on the numeric rating scale (NRS) (10 being the most severe). If their pain is at a level 5 or more and it is not responsive to traditional medical therapies, they will be a candidate for the study. The patients will receive bilateral injections as outlined below (5 mL: 4.5mL of 0.5% bupivacaine and 0.5mL of 10mg/mL dexamethasone on each side for total volume of 10 mL). Thirty minutes later and 24 hours following injection, the patient will rate their pain from 0-10 on the NRS. The description of the procedure is stated below. A success would be considered a drop in their pain score of at least 2.
Adverse effects will also be recorded 30 minutes after the procedure and the following day. Chart review on both provider and nursing notes will be performed on subsequent days to evaluate for adverse effects.
- Conditions
- Subarachnoid Hemorrhage, Headache
- Being tested
- Regional anesthetic SPG block-bilateral
- Keywords
- sphenopalatine ganglion block
- Medical subject headings
- Subarachnoid Hemorrhage, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional anesthetic SPG block-bilateralDrug
Patients will receive a 5mL injection comprised of 4.5mL 1% bupivacaine and 0.5mL of dexamethasone (10mg/mL) directed towards the sphenopalatine ganglion on each side (5 mL on each side)
| Study group | Role | What they receive |
|---|---|---|
| Open Label Arm | Experimental | Patients will receive a 5mL injection comprised of 4.5mL 1% bupivacaine and 0.5mL of dexamethasone (10mg/mL) directed towards the sphenopalatine ganglion. This will be performed on both sides. Patients will be asked to rate their pain pre- and 30 minutes post-procedure on a scale of 0-10. Patients will also be asked to rate their nausea and photophobia on a similar scale. Patients will be reevaluated at 24 hours and 48 hours post procedure. Receives: Drug: Regional anesthetic SPG block-bilateral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in patient reported pain using a standard numeric rating scale (NRS)
A combination of Bupivacaine 0.5% 4.5mL along with Dexamethasone 10mg/mL 0.5mL will be injected toward the sphenopalatine ganglion using a suprazygomatic approach bilaterally
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start1 Nov 2020
- Primary completion8 Apr 2024
- Study completion8 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Narayan R. Kissoon, Mayo Clinic
- Investigators
- Narayan Kissoon, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331938
- Sponsor's protocol ID
- 19-008846
- Status last verified
- Apr 2024
- First submitted
- 27 Mar 2020
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Landmark-guided Percutaneous Sphenopalatine Ganglion Block on Self-reported Headache Pain Secondary to Aneurysmal Subarachnoid Hemorrhage: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04331938
- Acronym / sponsor ID
- 19-008846
- Conditions
- Subarachnoid Hemorrhage, Headache
- Keywords
- sphenopalatine ganglion block
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 8 Apr 2024 (actual)
- Study completion
- 8 Apr 2024 (actual)
- First posted
- 2 Apr 2020 (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.
Researchers are trying to develop alternative means to help patients with headache pain secondary to aneurysmal subarachnoid hemorrhage (bleeding about the brain).
Detailed description
This study is an open label, feasibility study that will consist of fifteen patients. This study will enroll only patients who have aneurysmal SAH that are secured by endovascular coiling. When a patient notes a severe headache which requires medical intervention on at least day 3 of the hospital admission, they will be asked if they would like to participate in an open label trial to use a bilateral SSPGB in addition to traditional medical management per unit protocol. The risks and benefits of the procedure will be explained to the patient. The patient will then either agree or disagree. If the patient disagrees, they will not be enrolled in the study. If the patient agrees, they will sign an informed consent and will be enrolled. Inclusion and exclusion criteria will be reviewed before enrolling a patient. The patients will first rate their pain from 0-10 on the numeric rating scale (NRS) (10 being the most severe). If their pain is at a level 5 or more and it is not responsive to traditional medical therapies, they will be a candidate for the study. The patients will receive bilateral injections as outlined below (5 mL: 4.5mL of 0.5% bupivacaine and 0.5mL of 10mg/mL dexamethasone on each side for total volume of 10 mL). Thirty minutes later and 24 hours following injection, the patient will rate their pain from 0-10 on the NRS. The description of the procedure is stated below. A success would be considered a drop in their pain score of at least 2.
Adverse effects will also be recorded 30 minutes after the procedure and the following day. Chart review on both provider and nursing notes will be performed on subsequent days to evaluate for adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label Arm | Experimental | Drug: Regional anesthetic SPG block-bilateralPatients will receive a 5mL injection comprised of 4.5mL 1% bupivacaine and 0.5mL of dexamethasone (10mg/mL) directed towards the sphenopalatine ganglion. This will be performed on both sides. Patients will be asked to rate their pain pre- and 30 minutes post-procedure on a scale of 0-10. Patients will also be asked to rate their nausea and photophobia on a similar scale. Patients will be reevaluated at 24 hours and 48 hours post procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 and older
- Aneurysmal SAH in anterior/middle cerebral compartment
- Aneurysm must be secured endovascular with coiling
- The patient or patient's surrogate should be able to give informed consent and understand the risks of this study
- Pain NRS ≥ 5/10 in severity
Key exclusion criteria (4 listed)
- Non aneurysmal, traumatic SAH
- Posterior fossa aneurysm ruptures
- Pregnancy
- Transcranial Doppler velocities suggestive of or approaching vasospasm
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 |
|---|---|---|
| Regional anesthetic SPG block-bilateralPatients will receive a 5mL injection comprised of 4.5mL 1% bupivacaine and 0.5mL of dexamethasone (10mg/mL) directed towards the sphenopalatine ganglion on each side (5 mL on each side) | Drug | Open Label Arm |
Primary outcome
Reduction in patient reported pain using a standard numeric rating scale (NRS)
Time frame: 1 Day
A combination of Bupivacaine 0.5% 4.5mL along with Dexamethasone 10mg/mL 0.5mL will be injected toward the sphenopalatine ganglion using a suprazygomatic approach bilaterally
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 9 Apr 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Subarachnoid Hemorrhage
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
RecruitingObservational study
Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Spontaneous, Subarachnoid Hemorrhage, Aneurysmal
RecruitingObservational study
Smartphone Enabled Detection of Cognitive Motor Dissociation in the ICU
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke
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.
Narayan Kissoon, MD principal investigator
Mayo Clinic
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 Regional anesthetic SPG block-bilateral in people with Subarachnoid Hemorrhage and Headache, run by Mayo Clinic 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 5 inclusion and 4 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 9 Apr 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?
Reduction in patient reported pain using a standard numeric rating scale (NRS) (time frame: 1 Day). 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 9 Apr 2024.