SPG Block for Headaches from Subarachnoid Hemorrhage
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Recruiting
Sponsor: University of California, Davis
Disqualifiers: Unsecured aneurysm, Pregnant, others
No Placebo Group
Prior Safety Data
Approved in 2 Jurisdictions
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.
12345Is 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.
26789How 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.
134710Eligibility 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
+2 more
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
+5 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Transnasal SPG Block and Standard of Care MedicationsExperimental Treatment1 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 HeadacheActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UC Davis Medical CenterSacramento, CA
Loading ...
Who Is Running the Clinical Trial?
University of California, DavisLead Sponsor
Agnes Marshall Walker FoundationCollaborator
References
The effectiveness of preemptive sphenopalatine ganglion block on postoperative pain and functional outcomes after functional endoscopic sinus surgery. [2022]The sphenopalatine ganglion block (SPGB) with local anesthetic is used to treat facial pain and headache of various etiologies; it has been widely used during functional endoscopic sinus surgery (FESS). The purpose of this study was to investigate whether preemptive SPGB may positively impact postoperative pain and functional outcomes after FESS.
Lidocaine Versus Bupivacaine in the Treatment of Headache with Intranasal Sphenopalatine Nerve Block. [2020]Intranasal sphenopalatine ganglion (SPG) block has been shown to be an effective treatment for headaches. Multiple therapeutic agents have been studied, although the wide availability and low cost of lidocaine and bupivacaine have made them attractive treatment options. To the authors knowledge, no study has yet demonstrated superiority of one anesthetic over the other.
Images in anesthesiology: three safe, simple, and inexpensive methods to administer the sphenopalatine ganglion block. [2021]The sphenopalatine ganglion (SPG) block is a simple and valuable technique that was discovered over a century ago, but, unfortunately, very few anesthesiology providers are familiar with this block. After some of our recent publications, physicians from different countries have reached out to us requesting more specifics on how we perform our version of the block. In this report, we provide a brief history of the block and demonstrate our three effective, simple, readily available, and inexpensive methodologies with images. We are proud to share that our three SPG block techniques have so far effectively relieved patients of chronic migraines, acute migraines, tension headaches, moderate-to-severe back pain, and post-dural puncture headaches.
Sphenopalatine Ganglion Block in the Management of Chronic Headaches. [2022]Sphenopalatine ganglion (SPG) block has been used by clinicians in the treatment of a variety of headache disorders, facial pain syndromes, and other facial neuralgias. The sensory and autonomic fibers that travel through the SPG provided the scientific rationale for symptoms associated with these head and neck syndromes. Yet, despite the elucidation of this pathogenic target, the optimal method to block its pain-producing properties has not been determined. Clinicians have developed various invasive and non-invasive techniques, each of which has shown variable rates of success. We examined the available studies of sphenopalatine ganglion blockade and its efficacy in the treatment of cluster headaches, migraines, and other trigeminal autonomic cephalalgias.
Endoscopic sphenopalatine ganglion block for pain relief. [2021]The anaesthetic effect of the sphenopalatine (SPG) block has been well utilized for intranasal topical anaesthesia but the analgesic efficacy of (SPG) block, though well documented in literature, has not been put into practice. The methods available for SPG block till date were blind as they do not visualize the foramen. Nasal endoscopies have been used to visualize the foramen for an effective block. The authors present their experience with the endoscopic sphenopalatine ganglion block for pain relief in head and neck malignancies and neuralgias.
Trans-nasal sphenopalatine ganglion block for post-dural puncture headache management: a meta-analysis of randomized trials. [2023]To evaluate the efficacy and safety of trans-nasal Sphenopalatine Ganglion (SPG) block over other treatments for Post-Dural Puncture Headache (PDPH) management.
Early versus late sphenopalatine ganglion block with ropivacaine in postdural puncture headache: an observational study. [2023]Postdural puncture headache (PDPH) is a common complication of neuraxial techniques which delays patients.ÇÖ discharge. Sphenopalatine ganglion block (SPGB) is a safe bedside technique with comparable efficacy to Epidural Blood Patch, the gold-standard treatment. There is no evidence on the ideal timing for SPGB performance. We aimed to evaluate the difference between early versus late SPGB concerning efficacy, symptom recurrence and hospital length of stay.
Sphenopalatine ganglion block: a safe and easy method for the management of orofacial pain. [2019]The sphenopalatine ganglion (SPG) block is a safe, easy method for the control of acute or chronic pain in any pain management office. It takes only a few moments to implement, and the patient can be safely taught to effectively perform this pain control procedure at home with good expectations and results. Indications for the SPG blocks include pain of musculoskeletal origin, vascular origin and neurogenic origin. It has been used effectively in the management of temporomandibular joint (TMJ) pain, cluster headaches, tic douloureux, dysmenorrhea, trigeminal neuralgia, bronchospasm and chronic hiccup.
Transnasal Sphenopalatine Ganglion Block for Management of Postdural Puncture Headache in Non-Obstetric Patients. [2022]This study investigated the efficacy and safety of transnasal sphenopalatine ganglion block (SPGB) for treatment of postural puncture headache (PDPH) in non-obstetric patients.
[Sphenopalatine ganglion block for treatment of post-dural puncture headache]. [2020]In this review, we discuss transnasal sphenopalatine ganglion (SPG) block: a new, simple and minimally invasive procedure for the treatment of post-dural puncture headache (PDPH) by applying local anaesthesia through the patient's nose to the nasopharynx. PDPH is a severe and disabling complication sometimes caused by lumbar puncture or unintentional dural puncture. Current treatment includes epidural blood patch, which is an invasive and resource-demanding procedure with the potential of causing severe complications such as infection and paralysis. SPG block seems to be effective and may ease and improve the treatment of PDPH.