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Efficacy of Percutaneous SPG Block in Aneurysmal SAH

The Efficacy of Landmark-guided Percutaneous Sphenopalatine Ganglion Block on Self-reported Headache Pain Secondary to Aneurysmal Subarachnoid Hemorrhage: A Feasibility Study

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04331938
Enrollment
2
Registered
2020-04-02
Start date
2020-11-01
Completion date
2024-04-08
Last updated
2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Headache, Subarachnoid Hemorrhage

Keywords

sphenopalatine ganglion block

Brief summary

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.

Interventions

DRUGRegional anesthetic SPG block-bilateral

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)

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Non aneurysmal, traumatic SAH * Posterior fossa aneurysm ruptures * Pregnancy * Transcranial Doppler velocities suggestive of or approaching vasospasm

Design outcomes

Primary

MeasureTime frameDescription
Reduction in patient reported pain using a standard numeric rating scale (NRS)1 DayA 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026