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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Transnasal Sphenopalatine Ganglion 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. It has been used successfully for pain relief in different head and neck conditions, suggesting it may also help with headaches from subarachnoid hemorrhage. ^{1 2 3 4 5}

Is the SPG Block safe for treating headaches?

The SPG Block is considered a safe method for managing various types of pain, including headaches. It is a simple procedure that can be performed at home and has been used effectively for conditions like cluster headaches and other pain types. ^{2 6 7 8 9}

How is the SPG Block treatment different from other treatments for headaches from subarachnoid hemorrhage?

The SPG Block is unique because it is a simple, minimally invasive procedure that involves applying local anesthesia through the nose to target the sphenopalatine ganglion, which can help relieve headaches. Unlike more invasive treatments like the epidural blood patch, the SPG Block is less resource-intensive and has fewer risks of severe complications. ^{1 3 4 7 10}

Research Team

Christine Picinich, MS, AGACNP-BC, CCRN

Principal Investigator

University of California, Davis

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The effectiveness of preemptive sphenopalatine ganglion block on postoperative pain and functional outcomes after functional endoscopic sinus surgery. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Lidocaine Versus Bupivacaine in the Treatment of Headache with Intranasal Sphenopalatine Nerve Block. [2020]

3. England pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Sphenopalatine Ganglion Block in the Management of Chronic Headaches. [2022]

5. India pubmed.ncbi.nlm.nih.gov

Endoscopic sphenopalatine ganglion block for pain relief. [2021]

6. Brazil pubmed.ncbi.nlm.nih.gov

Trans-nasal sphenopalatine ganglion block for post-dural puncture headache management: a meta-analysis of randomized trials. [2023]

7. Brazil pubmed.ncbi.nlm.nih.gov

Early versus late sphenopalatine ganglion block with ropivacaine in postdural puncture headache: an observational study. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Sphenopalatine ganglion block: a safe and easy method for the management of orofacial pain. [2019]

9. Japan pubmed.ncbi.nlm.nih.gov

Transnasal Sphenopalatine Ganglion Block for Management of Postdural Puncture Headache in Non-Obstetric Patients. [2022]

10. Denmark pubmed.ncbi.nlm.nih.gov

[Sphenopalatine ganglion block for treatment of post-dural puncture headache]. [2020]