SPG Block for Headaches from Subarachnoid Hemorrhage

Overseen By Ryan Martin, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: University of California, Davis

Disqualifiers: Unsecured aneurysm, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for treating headaches caused by a subarachnoid hemorrhage. Researchers are evaluating the effectiveness of a transnasal sphenopalatine ganglion (SPG) block, which numbs a nerve inside the nose, in combination with standard headache medications. The aim is to determine if this approach can lessen headache severity and reduce opioid use in the hospital and after discharge. This trial suits individuals who have experienced a subarachnoid hemorrhage and can communicate their pain levels. As a Phase 2, Phase 3 trial, it assesses the treatment's effectiveness in a smaller group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in headache treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the transnasal sphenopalatine ganglion block is safe for treating headaches from subarachnoid hemorrhage?

Research has shown that the transnasal sphenopalatine ganglion (SPG) block is generally well-tolerated. One study found that SPG blocks provide a safe and quick method for managing various types of headaches. Although it did not consistently outperform other treatments in every study, it has successfully reduced headache pain.

No major safety issues have been consistently reported, indicating that serious side effects are rare. However, like any treatment, minor side effects can occur, but they are usually not severe. Prospective trial participants should discuss any concerns with the trial team or a healthcare provider. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for headaches?

Researchers are excited about the transnasal Sphenopalatine Ganglion (SPG) block for headaches caused by subarachnoid hemorrhage because it offers a new delivery method that targets pain relief directly at the source. Unlike standard treatments like pain medications and anti-inflammatory drugs, which work systemically, the SPG block delivers relief right through the nasal passages to the ganglion responsible for headache signals. This targeted approach could lead to quicker and potentially more effective pain management, with fewer side effects compared to systemic medications.

What evidence suggests that the transnasal SPG block is effective for headaches from subarachnoid hemorrhage?

Research has shown that the sphenopalatine ganglion block (SPG block) effectively treats various headaches, such as migraines and tension headaches. In this trial, one group of participants will receive standard care medications, while another group will receive a transnasal SPG block in addition to standard pain medication. Studies suggest that adding a transnasal SPG block may reduce headache severity in individuals with acute subarachnoid hemorrhage, a type of brain bleed. Initial findings also indicate that SPG blocks might lessen the need for opioids, strong painkillers, during and after hospital stays. This treatment targets nerves linked to headache pain, offering a new way to manage symptoms beyond typical pain medications. ^{1 2 4 6 7}

Who Is on the Research Team?

Christine Picinich, MS, AGACNP-BC, CCRN

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

This trial is for adults over 18 with acute subarachnoid hemorrhage (aSAH) from a secured brain aneurysm, who can express their pain level. A patient or surrogate must consent to participate. It's not suitable for those unable to communicate pain or without decision-making capacity.

Inclusion Criteria

Secured aneurysm

I have had a recent bleeding in the brain.

Patient or surrogate decision maker is available to consent

Exclusion Criteria

Pregnant or lactating

Unable to verbalize pain score to clinician, nurse, medical translator, or surrogate decision maker

Allergy to lidocaine, bupivacaine, or dexamethasone

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either standard care medications or standard care plus transnasal SPG block for headache management

2 weeks

Daily monitoring in ICU

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain scores and opioid usage

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transnasal Sphenopalatine Ganglion Block

Trial Overview The study tests if a transnasal sphenopalatine ganglion block can better manage headache severity in aSAH patients compared to standard pain meds alone and if it reduces the need for opioids during and after hospital stay.

How Is the Trial Designed?

Group I: Transnasal SPG Block and Standard of Care Medications Experimental Treatment 1 Intervention

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.

Group II: Standard of Care Medications for Headache Active Control 1 Intervention

Control arm participants will receive standard of care medications, as defined in a headache protocol, to treat subarachnoid associated headache.

Transnasal Sphenopalatine Ganglion Block is already approved in United States, European Union for the following indications:

Approved in United States as Sphenopalatine Ganglion Block for:

• Migraines
• Cluster headaches
• Trigeminal neuralgia
• Paroxysmal hemicranias
• Atypical facial pain

Approved in European Union as Sphenopalatine Ganglion Block for:

• Migraines
• Cluster headaches
• Trigeminal neuralgia
• Facial pain syndromes

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Agnes Marshall Walker Foundation

Collaborator

Trials

2

Recruited

70+

Published Research Related to This Trial

In a study of 41 patients with postdural puncture headache (PDPH), early sphenopalatine ganglion block (SPGB) performed within 24 hours of diagnosis significantly reduced hospital length of stay and symptom recurrence compared to late SPGB.

Both early and late SPGB provided equally effective pain relief, suggesting that timing of the intervention can optimize patient outcomes and potentially lower healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early versus late sphenopalatine ganglion block with ropivacaine in postdural puncture headache: an observational study. Santos, NS., Nunes, JM., Font, ML., et al.[2023]

Sphenopalatine ganglion (SPG) blockade has been shown to provide pain relief for patients suffering from cluster headaches, migraines, and other trigeminal autonomic cephalalgias, indicating its efficacy as a treatment option.

Current studies suggest that SPG blockade is a safe intervention, but the effectiveness can vary based on the techniques used and the choice of medications, highlighting the need for further research to optimize treatment methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sphenopalatine Ganglion Block in the Management of Chronic Headaches. Mojica, J., Mo, B., Ng, A.[2022]

Trans-nasal Sphenopalatine Ganglion (SPG) block is more effective than conservative treatments and intranasal lignocaine puffs for short-term pain relief from Post-Dural Puncture Headache (PDPH), based on a meta-analysis of 9 randomized controlled trials involving 1748 articles.

However, the SPG block did not show significant advantages over conservative treatments beyond 6 hours, nor did it demonstrate superiority in safety or efficacy compared to sham treatments and Greater Occipital Nerve blocks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trans-nasal sphenopalatine ganglion block for post-dural puncture headache management: a meta-analysis of randomized trials. Dwivedi, P., Singh, P., Patel, TK., et al.[2023]

Transnasal sphenopalatine ganglion block (SPGB) effectively relieved postural puncture headache (PDPH) in 26 non-obstetric patients, with nearly half reporting no pain 24 hours after the procedure and all patients achieving a low pain score.

The procedure was found to be safe and well-tolerated, with only mild adverse effects like nasal discomfort and throat numbness, which resolved within 24 hours, and a high patient satisfaction rate, with 73.1% of patients feeling 'much improved' after 48 hours.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transnasal Sphenopalatine Ganglion Block for Management of Postdural Puncture Headache in Non-Obstetric Patients. Takmaz, SA., Karaoğlan, M., Baltacı, B., et al.[2022]

The sphenopalatine ganglion (SPG) block is a quick and safe method for managing both acute and chronic pain, making it suitable for use in pain management offices.

This technique can be effectively taught to patients for at-home use, and it has shown efficacy in treating various pain conditions, including TMJ pain, cluster headaches, and trigeminal neuralgia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sphenopalatine ganglion block: a safe and easy method for the management of orofacial pain. Peterson, JN., Schames, J., Schames, M., et al.[2019]

In a study of 60 patients undergoing functional endoscopic sinus surgery (FESS), preemptive sphenopalatine ganglion block (SPGB) with bupivacaine showed a trend towards reduced postoperative pain compared to a saline control, although this difference was not statistically significant.

While the SPGB did not significantly improve other functional outcomes like the Sino-Nasal Outcome Test (SNOT-20) or CT and endoscopic scores, the results suggest potential benefits that warrant further investigation in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of preemptive sphenopalatine ganglion block on postoperative pain and functional outcomes after functional endoscopic sinus surgery. Cho, DY., Drover, DR., Nekhendzy, V., et al.[2022]

The sphenopalatine ganglion (SPG) block is an underutilized technique that has been effectively used to relieve various types of headaches, including chronic migraines and tension headaches, as well as moderate-to-severe back pain.

The report outlines three simple and cost-effective methodologies for performing the SPG block, which have shown positive results in pain relief for patients, highlighting its potential as a valuable tool in pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Images in anesthesiology: three safe, simple, and inexpensive methods to administer the sphenopalatine ganglion block. Levin, D., Cohen, S.[2021]

Transnasal sphenopalatine ganglion (SPG) block is a new, minimally invasive procedure that effectively treats post-dural puncture headache (PDPH) by delivering local anesthesia through the nose to the nasopharynx.

Unlike the traditional epidural blood patch, which is invasive and carries risks of severe complications, SPG block offers a safer alternative for managing PDPH with potentially fewer side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Sphenopalatine ganglion block for treatment of post-dural puncture headache]. Jespersen, MS., Jæger, PT., Ægidius, KL., et al.[2020]

A retrospective study of 386 patients receiving intranasal sphenopalatine ganglion (SPG) blocks found that both lidocaine and bupivacaine were effective in reducing headache pain, with 90.2% of treatments resulting in decreased pain levels.

There was no statistically significant difference in efficacy between lidocaine and bupivacaine, suggesting that both anesthetics are viable options for SPG blocks, although the choice may depend on the specific delivery device used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lidocaine Versus Bupivacaine in the Treatment of Headache with Intranasal Sphenopalatine Nerve Block. Kirkpatrick, DL., Townsend, T., Walter, C., et al.[2020]

The endoscopic sphenopalatine ganglion (SPG) block is a promising technique for providing analgesic relief in patients with head and neck malignancies and neuralgias, enhancing the effectiveness of pain management.

This method improves upon traditional blind techniques by allowing visualization of the foramen, potentially leading to more accurate and effective pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic sphenopalatine ganglion block for pain relief. Murty, PS., Prasanna, A.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06621329

Transnasal Sphenopalatine Ganglion Block for Treatment ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10625157/

Trans-nasal sphenopalatine ganglion block for post-dural ... To evaluate the efficacy and safety of trans-nasal Sphenopalatine Ganglion (SPG) block over other treatments for Post-Dural Puncture Headache (PDPH) management.

3. withpower.com withpower.com/trial/phase-2-and-3-sah-subarachnoid-hemorrhage-9-2024-7876c

SPG Block for Headaches from Subarachnoid Hemorrhage Research shows that the sphenopalatine ganglion block (SPG block) is effective in treating various types of headaches, including migraines and tension headaches ...

4. mdpi.com mdpi.com/2076-3425/15/7/672

Sphenopalatine Ganglion Blocks in Headache Management This review consolidates anatomical and pathophysiological insights, procedural techniques, and clinical efficacy data to provide a comprehensive overview of ...

5. clinicaltrials.ucbraid.org clinicaltrials.ucbraid.org/trial/NCT06621329

Transnasal Sphenopalatine Ganglion Block for Treatment of ... The study is designed to test the hypothesis that the addition of a transnasal SPG block to standard pain medication is more effective than ...

6. americanmigrainefoundation.org americanmigrainefoundation.org/resource-library/sphenopalatine-ganglion-blocks/

Sphenopalatine Ganglion Blocks in Headache Disorders SPG block, using one of these three catheters, is a safe, quick, and effective way to reduce the severity and frequency of various headache disorders for a ...

7. link.springer.com link.springer.com/article/10.1007/s12028-024-02078-z

Rationale and Design for the BLOCK-SAH Study ... The BLOCK-SAH trial was designed to assess the efficacy and safety of bilateral PPF-blocks in awake patients with severe headaches from aneurysmal SAH.