SAH (Subarachnoid Hemorrhage)Phase 2/3NCT06621329
Transnasal Sphenopalatine Ganglion Block for Treatment of Acute Subarachnoid Hemorrhage Associated Headache
A Phase 2/3 study testing Transnasal sphenopalatine ganglion block in people with SAH (Subarachnoid Hemorrhage) and Headache, run by University of California, Davis at 1 site in United States.
Trial summary
The study titled \"Transnasal sphenopalatine ganglion block for treatment of acute subarachnoid hemorrhage associated headache\" is a randomized controlled pilot study aimed at evaluating the efficacy of a transnasal sphenopalatine ganglion (SPG) block in addition to standard pain medication for reducing… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- SAH (Subarachnoid Hemorrhage), Headache
- What is being tested?
- Transnasal sphenopalatine ganglion block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2024to Oct 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute subarachnoid hemorrhage
- Age greater than 18 years
- Secured aneurysm
- Patient can verbalize pain score to clinician, nurse, medical translator, or surrogate decision
- maker
- Patient or surrogate decision maker is available to consent
Who cannot join
- Less than 18 years old
- Unsecured aneurysm
- Pregnant or lactating
- Prisoner
- Unable to verbalize pain score to clinician, nurse, medical translator, or surrogate decision maker
- Nasal or facial trauma or surgery within the last three months
- Allergy to lidocaine, bupivacaine, or dexamethasone
- Patient is unable to consent and no available surrogate decision maker
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UC Davis Medical Center
Sacramento, California, 95817
Christine Picinich, AGACNP-BC, MS, 7075368452, cpicinich@ucdavis.edu
Christine Picinich
About this study
The study titled \"Transnasal sphenopalatine ganglion block for treatment of acute subarachnoid hemorrhage associated headache\" is a randomized controlled pilot study aimed at evaluating the efficacy of a transnasal sphenopalatine ganglion (SPG) block in addition to standard pain medication for reducing headache severity in patients with acute subarachnoid hemorrhage (aSAH). The study also examines whether this intervention can reduce opioid requirements during hospitalization and upon discharge.
Read the detailed description
The study is designed to test the hypothesis that the addition of a transnasal SPG block to standard pain medication is more effective than medication alone in reducing headache associated with acute subarachnoid hemorrhage. It involves 40 participants who meet specific inclusion criteria, such as being over 18 years old, having a secured aneurysm, and the ability to verbalize pain scores. Those with conditions like recent nasal or facial trauma, allergies to specific anesthetics, or pregnancy are excluded.
Participants are randomized into two groups: one receiving the standard care medication for headache and the other receiving both the standard care and a transnasal SPG block. The SPG block is administered using a needleless device called the Tx360, which allows for the medication to be instilled directly to the the sphenopalatine ganglion via the nasal passageways.
Data on pain scores and opioid usage are collected and analyzed using statistical methods to assess the effectiveness of the SPG block. The study also includes safety monitoring to track any adverse effects from the intervention. The entire study spans approximately 24 months, with individual participation lasting up to four weeks.
- Conditions
- SAH (Subarachnoid Hemorrhage), Headache
- Being tested
- Transnasal sphenopalatine ganglion block
- Keywords
- aSAH, peripheral nerve block, sphenopalatine ganglion, subarachnoid hemorrhage, headache
- 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.
Transnasal sphenopalatine ganglion blockCombination product
Also called SPG block, peripheral nerve block
Transnasal sphenopalatine ganglion blocks will be performed using the Tx360 device. Medications used during the procedure include 0.75% bupivacaine with or without 1 mg of preservative free dexamethasone.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Medications for Headache | No intervention | Control arm participants will receive standard of care medications, as defined in a headache protocol, to treat subarachnoid associated headache. |
| Transnasal SPG Block and Standard of Care Medications | Experimental | Intervention arm participants will receive standard of care medications, as defined in a headache protocol, with the addition of transnasal SPG blocks when a predefined threshold is met per the study protocol. Receives: Combination Product: Transnasal sphenopalatine ganglion block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical pain rating scale
Pain scores will be obtained at regular intervals to compare pain control between the two arms. Pain scores will be collected multiple times throughout each ICU day, up to ICU day 14.
Measured: From enrollment until ICU discharge, up to 14 days
Secondary outcomes (1)
Morphine milligram equivalents (MME)
Total Morphine milligram equivalents per ICU day will be collected for up to 14 days. Total morphine milligram equivalents will also be collected on the day of hospital discharge. Total morphine milligram equivalents for ICU course and total morphine milligram equivalents on day of discharge will be compared between the two arms.
Measured: From enrollment to hospital discharge, up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start17 Oct 2024
- Primary completionJul 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SAH (Subarachnoid Hemorrhage)Studies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Both arms will receive standard of care medications for headache management. The intervention group will receive an SPG block at a specific threshold defined in the study protocol.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Agnes Marshall Walker Foundation
- Responsible party
- Sponsor
- Investigators
- Christine Picinich, MS, AGACNP-BC, CCRN, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621329
- Sponsor's protocol ID
- 2160233
- Status last verified
- Aug 2026
- First submitted
- 25 Sep 2024
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transnasal Sphenopalatine Ganglion Block for Treatment of Acute Subarachnoid Hemorrhage Associated Headache
- ClinicalTrials.gov ID
- NCT06621329
- Acronym / sponsor ID
- 2160233
- Conditions
- SAH (Subarachnoid Hemorrhage), Headache
- Keywords
- aSAH, peripheral nerve block, sphenopalatine ganglion, subarachnoid hemorrhage, headache
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Agnes Marshall Walker Foundation
- Study start
- 17 Oct 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 1 Oct 2024 (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 study titled \"Transnasal sphenopalatine ganglion block for treatment of acute subarachnoid hemorrhage associated headache\" is a randomized controlled pilot study aimed at evaluating the efficacy of a transnasal sphenopalatine ganglion (SPG) block in addition to standard pain medication for reducing headache severity in patients with acute subarachnoid hemorrhage (aSAH). The study also examines whether this intervention can reduce opioid requirements during hospitalization and upon discharge.
Detailed description
The study is designed to test the hypothesis that the addition of a transnasal SPG block to standard pain medication is more effective than medication alone in reducing headache associated with acute subarachnoid hemorrhage. It involves 40 participants who meet specific inclusion criteria, such as being over 18 years old, having a secured aneurysm, and the ability to verbalize pain scores. Those with conditions like recent nasal or facial trauma, allergies to specific anesthetics, or pregnancy are excluded.
Participants are randomized into two groups: one receiving the standard care medication for headache and the other receiving both the standard care and a transnasal SPG block. The SPG block is administered using a needleless device called the Tx360, which allows for the medication to be instilled directly to the the sphenopalatine ganglion via the nasal passageways.
Data on pain scores and opioid usage are collected and analyzed using statistical methods to assess the effectiveness of the SPG block. The study also includes safety monitoring to track any adverse effects from the intervention. The entire study spans approximately 24 months, with individual participation lasting up to four weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Both arms will receive standard of care medications for headache management. The intervention group will receive an SPG block at a specific threshold defined in the study protocol.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Medications for Headache | No intervention | –Control arm participants will receive standard of care medications, as defined in a headache protocol, to treat subarachnoid associated headache. |
| Transnasal SPG Block and Standard of Care Medications | Experimental | Combination Product: Transnasal sphenopalatine ganglion blockIntervention arm participants will receive standard of care medications, as defined in a headache protocol, with the addition of transnasal SPG blocks when a predefined threshold is met per the study protocol. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Acute subarachnoid hemorrhage
- Age greater than 18 years
- Secured aneurysm
- Patient can verbalize pain score to clinician, nurse, medical translator, or surrogate decision
- maker
Key exclusion criteria (8 listed)
- Less than 18 years old
- Unsecured aneurysm
- Pregnant or lactating
- Prisoner
- Unable to verbalize pain score to clinician, nurse, medical translator, or surrogate decision maker
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 |
|---|---|---|
| Transnasal sphenopalatine ganglion blockAlso: SPG block, peripheral nerve blockTransnasal sphenopalatine ganglion blocks will be performed using the Tx360 device. Medications used during the procedure include 0.75% bupivacaine with or without 1 mg of preservative free dexamethasone. | Combination product | Transnasal SPG Block and Standard of Care Medications |
Primary outcome
Numerical pain rating scale
Time frame: From enrollment until ICU discharge, up to 14 days
Pain scores will be obtained at regular intervals to compare pain control between the two arms. Pain scores will be collected multiple times throughout each ICU day, up to ICU day 14.
1 secondary outcome
Morphine milligram equivalents (MME)
Time frame: From enrollment to hospital discharge, up to 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Christine Picinich, MS, AGACNP-BC, CCRN principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Transnasal sphenopalatine ganglion block in people with SAH (Subarachnoid Hemorrhage) and Headache, run by University of California, Davis 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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 18 Aug 2026. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janice Wang-Polagruto, PhD, CCRP (916-551-3244, jfwang@ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical pain rating scale (time frame: From enrollment until ICU discharge, up to 14 days). 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 18 Aug 2026.