Efficacy of Percutaneous SPG Block in Aneurysmal SAH

NCT04331938 | Completed Phase 1 FDA Drug

• 1 other identifier: 19-008846
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Subarachnoid Hemorrhage; Headache

Keywords

sphenopalatine ganglion block

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Open Label Arm

EXPERIMENTAL

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

Interventions

Regional anesthetic SPG block-bilateral DRUG

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)

Open Label Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Headache

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Narayan Kissoon, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 27, 2020
• First Posted: April 2, 2020
• Study Start: November 1, 2020
• Primary Completion: April 8, 2024
• Study Completion: April 8, 2024
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)