Pterygopalatine Fossa Block in Aneurysmal Subarachnoid Hemorrhage

Aneurysmal subarachnoid hemorrhage (aSAH) can cause a severe headache (HA) that is famously treatment-resistant. Current pain regimens are too reliant on opioids, which results in long-term opioid dependence and can obfuscate the neurological examination, which is critical to detect vasospasm and delayed cerebral ischemia. This study will gather the initial evidence of whether the pterygopalatine fossa (PPF) regional anesthesia nerve block can treat aSAH-related HA and reduce opioid consumption in patients with aSAH.

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Key information

Conditions

Subarachnoid Hemorrhage, Aneurysmal Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Subarachnoid Hemorrhage Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

UT Southwestern

Dallas, Texas, 75235, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Aneurysmal subarachnoid hemorrhage with secured aneurysm
Age greater than or equal to 18 years
Able to communicate pain level

Exclusion criteria

Documented allergy to local anesthetics (e.g. bupivicaine)
Patients with unsecured aneurysms
Patients who are unable to communicate pain level (e.g. sedation/mechanical ventilation/delirium, etc)
Medical treatment for vasospasm including blood pressure/inotropic augmentation
Angiographic treatment for vasospasm within 48 hours

Treatment and study plan

Ptergyopalatine Fossa Block

Procedure

Injection of local anesthetic (e.g. Bupivacaine) into the pterygopalatine fossa to treat headache related to aneurysmal subarachnoid hemorrhage

Bupivacaine 0.25% Injectable Solution

Drug

Injection of local anesthetic (e.g. Bupivacaine) into the pterygopalatine fossa to treat headache related to aneurysmal subarachnoid hemorrhage

Primary outcomes

Opioid consumption

Time frame: 3 days
Pain Rating Scale

Time frame: 3 days

Scale of 1-10, 1 being lowest possible pain, 10 being highest possible pain

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Jun 29, 2023
Registry last updated: Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed