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

Researchers are trying to develop alternative means to help patients with headache pain secondary to aneurysmal subarachnoid hemorrhage (bleeding about the brain).

Study Overview

• Status: Completed
• Conditions: Headache; Subarachnoid Hemorrhage
• Intervention / Treatment: Drug: Regional anesthetic SPG block-bilateral

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Open Label Arm; Patients will receive a 5mL injection comprised of 4.5mL 1% bupivacaine and 0.5mL of dexamethasone (10mg/mL) directed towards the sphenopalatine ganglion. This will be performed on both sides. Patients will be asked to rate their pain pre- and 30 minutes post-procedure on a scale of 0-10. Patients will also be asked to rate their nausea and photophobia on a similar scale. Patients will be reevaluated at 24 hours and 48 hours post procedure.

Drug: Regional 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in patient reported pain using a standard numeric rating scale (NRS)	A 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	1 Day

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Narayan Kissoon, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): April 8, 2024
• Study Completion (Actual): April 8, 2024

Study Registration Dates

• First Submitted: March 27, 2020
• First Submitted That Met QC Criteria: April 1, 2020
• First Posted (Actual): April 2, 2020

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: sphenopalatine ganglion block
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Intracranial Hemorrhages; Hemorrhage; Headache; Subarachnoid Hemorrhage; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 19-008846

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No