Pterygopalatine Fossa Block in Aneurysmal Subarachnoid He... | NCT05925478

Studies
Pterygopalatine Fossa Block in Aneurysmal Subarachnoid Hemorrhage

NCT05925478

Sponsor

University of Texas Southwestern Medical Center

Status

Completed

Last Update Posted

Aug 22, 2024Actual

Enrollment

2Actual

Phase

Early Phase 1

Conditions

Subarachnoid Hemorrhage, Aneurysmal

Interventions

Ptergyopalatine Fossa Block
Bupivacaine 0.25% Injectable Solution

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 6, 2023Actual

Primary Completion Date

Aug 20, 2024Actual

Completion Date

Aug 20, 2024Actual

First Submitted Date

Jun 21, 2023

First Submission Date that Met QC Criteria

Jun 21, 2023

First Posted Date

Jun 29, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2024

Last Update Posted Date

Aug 22, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Noah Jouett, Fellow Physician, University of Texas Southwestern Medical CenterPrincipal Investigator

Lead Sponsor

University of Texas Southwestern Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment arm	Experimental		Procedure: Ptergyopalatine Fossa Block Drug: Bupivacaine 0.25% Injectable Solution

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ptergyopalatine Fossa Block	Procedure	Injection of local anesthetic (e.g. Bupivacaine) into the pterygopalatine fossa to treat headache related to aneurysmal subarachnoid hemorrhage

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Opioid consumption		3 days
Pain Rating Scale	Scale of 1-10, 1 being lowest possible pain, 10 being highest possible pain	3 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UT Southwestern		Dallas	Texas	75235	United States

Condition Browse Module

MeSH Terms

ID	Term
D013345	Subarachnoid Hemorrhage

Ancestor Terms

ID	Term
D020300	Intracranial Hemorrhages
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002045	Bupivacaine

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

Browse Leaves

Not provided

Browse Branches

Not provided