Actively Recruiting

Phase 2
Age: 18Years - 85Years
All Genders
ID06008795

Pterygopalatine Fossa Block as an Opioid Sparing Treatment for Acute Headache in Spontaneous Subarachnoid Hemorrhage

Led by University of Florida · Updated on 2025-11-28

195

Participants Needed

11

Research Sites

6 weeks

Total Duration

On this page

Sponsors

U

University of Florida

Lead Sponsor

N

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the use of nerve block injections in the pterygopalatine fossa (PPF) to manage headaches in people who have survived aneurysmal subarachnoid hemorrhage (SAH). This phase II, multicenter, randomized, double-blinded, placebo-controlled clinical trial compares active PPF nerve blocks containing ropivacaine and dexamethasone to placebo saline injections. The study also monitors blood flow in brain arteries using transcranial Doppler during the treatment periods to assess safety and effects. Participants are randomly assigned to one of three groups: one receiving active PPF nerve blocks in both stages, one receiving placebo injections followed by active blocks, and one receiving placebo injections in both stages. Each active injection contains 20mg ropivacaine plus 4mg dexamethasone, while placebo injections consist of saline. The treatment phase spans 48 hours with two injection stages, followed by assessments for safety and tolerability. During the study, participants provide pain scale scores and undergo monitoring of intracranial artery flow velocities with transcranial Doppler. Researchers evaluate pain relief within 24 hours after each injection and monitor safety up to 48 hours from the first injection. Participants must be available for the study duration and comply with procedures, which include neurological assessments and tracking of headache symptoms. This trial seeks to better understand the potential of PPF nerve blocks as an opioid-sparing treatment for acute headache after SAH.

CONDITIONS

Brief Title

BLOCK-SAH - PPF-Block for Post-SAH Headache

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent given by participant or legally authorized representative
  • Willingness to comply with all study procedures and availability for study duration
  • Male or female aged 18 to 85 years
  • Admission with primary diagnosis of spontaneous, non-traumatic subarachnoid hemorrhage within 72 hours of hemorrhage onset
  • Spontaneous, non-traumatic SAH with subarachnoid hemorrhage pattern involving specific brain regions
  • Modified Fisher grade 1-4 on presentation imaging
  • Hunt and Hess 1-3 or World Federation of Neurosurgeons grade 1-4 with Glasgow Coma Scale verbal subscore of at least 4
  • Ability to verbalize pain on an 11-point numeric pain scale
  • Minimum 4 hours stabilization after clipping or coiling procedure when applicable
  • Successful treatment of aneurysm with at least 90% obliteration when applicable
  • Requirement of at least 15mg oral morphine equivalent for headache analgesia in any 24-hour period during eligibility
Not Eligible

You will not qualify if you...

  • Pre-existing neurological, psychiatric, or other conditions interfering with neurological and functional assessment
  • Pre-existing diffuse arterial narrowing in Circle of Willis from any cause
  • Prior opioid or barbiturate use for at least two-thirds of previous month
  • Substance use disorder diagnosis within past year
  • Infection or wound at planned injection site
  • Uncorrected coagulopathy including platelet count below 50,000/µL or INR above 1.7
  • Requirement for systemic anticoagulation or antiplatelet therapy except aspirin alone
  • Head trauma as cause of SAH
  • Infection causing aneurysm or SAH such as mycotic aneurysms
  • Failure to successfully treat culprit vascular lesion
  • Diffuse vasospasm on pre-enrollment imaging not due to other causes
  • Elevated liver enzymes prohibiting acetaminophen use
  • Chronic liver condition contraindicating acetaminophen
  • Participation in other investigational interventional studies
  • Known pregnancy or positive pregnancy test
  • Allergy or intolerance to study medications or standard pain regimen
  • Vulnerable populations such as prisoners
  • Inability to receive first PPF injection within 96 hours of hemorrhage onset

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 48 hours

Participants receive either active Pterygopalatine Fossa nerve blocks or placebo injections during a double-blinded treatment period.

2 visits for injections within 48 hours

Trial Site Locations

Total: 11 locations

1

University of Florida

Gainesville, Florida, United States, 32610

Actively Recruiting

2

Emory University

Atlanta, Georgia, United States, 30322

Actively Recruiting

3

University of Maryland Baltimore

Baltimore, Maryland, United States, 21201

Actively Recruiting

4

Mayo Clinic

Rochester, Minnesota, United States, 55009

Actively Recruiting

5

Albany Medical College

Albany, New York, United States, 12208

Actively Recruiting

6

University of Rochester Medical College

Rochester, New York, United States, 14642

Actively Recruiting

7

University of Cincinnati

Cincinnati, Ohio, United States, 45267

Actively Recruiting

8

Oregon Health and Sciences University

Portland, Oregon, United States, 97239

Actively Recruiting

9

Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

Not Yet Recruiting

10

University of Washington

Seattle, Washington, United States, 98104

Actively Recruiting

11

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

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Research Team

Y

Yurerkis Montas

R

Ralisa Pop

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

Rationale and Design for the BLOCK-SAH Study (Pterygopalatine Fossa Block as an Opioid-Sparing Treatment for Acute Headache in Aneurysmal Subarachnoid Hemorrhage): A Phase II, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial with a Sequential Parallel Comparison Design.

Katharina M Busl, Cameron R Smith, Andrea B Troxel...

https://pubmed.ncbi.nlm.nih.gov/39138719