Pterygopalatine Fossa Block in Aneurysmal Subarachnoid Hemorrhage

NCT ID: NCT05925478

Last Updated: 2024-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-06

Study Completion Date

2024-08-20

Brief Summary

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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.

Detailed Description

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Conditions

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Subarachnoid Hemorrhage, Aneurysmal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment arm

Group Type EXPERIMENTAL

Ptergyopalatine Fossa Block

Intervention Type 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

Intervention Type DRUG

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

Interventions

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Ptergyopalatine Fossa Block

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

Intervention Type PROCEDURE

Bupivacaine 0.25% Injectable Solution

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Noah Jouett

Fellow Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UT Southwestern

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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STU-2023-0176

Identifier Type: -

Identifier Source: org_study_id

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