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

Phase 2

Recruiting

• Conditions: Headache; Subarachnoid Hemorrhage, Aneurysmal
• Interventions: Drug: Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone; Procedure: Placebo Pteryogpalatine Fossa Injection

• Registration Number: NCT06008795
• Lead Sponsor: University of Florida

Brief Summary

BLOCK-SAH is a phase II, multicenter, randomized, double-blinded, placebo-controlled clinical trial with a sequential parallel comparison design (SPCD) of bilateral pterygopalatine fossa (PPF) injections with 20mg ropivacaine + 4mg dexamethasone (active, PPF-block) compared to saline (placebo) for headache in survivors of aneurysmal subarachnoid hemorrhage (SAH), while monitoring intracranial arterial mean flow velocities with transcranial Doppler (TCD) peri-intervention (intervention = PPF-injections: active or placebo)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-18
• Study First Submitted QC: 2023-08-18
• Study First Posted: 2023-08-24
• Study Start: 2023-12-17
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-14
• Primary Completion: 2027-01-15
• Study Completion: 2027-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 195

Inclusion Criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Provision of signed and dated ICF

2. Stated willingness to comply with all study procedures and availability for the duration of the study

3. Male or female, aged ≥18 and ≤ 85 years

4. Admitted with a primary diagnosis of spontaneous, non-traumatic, SAH within 48 hours of ictus hemorrhage

5. Disease-specific inclusion criteria:

   1. Spontaneous, non-traumatic SAH
   2. Subarachnoid pattern of hemorrhage warranting diagnostic DSA due to involvement of at least one of the following regions: quadrigeminal plate, prepontine cistern, perimesencephalic cistern, Sylvian fissure, or surrounding Circle of Willis
   3. Modified Fisher grade 1-4 (on presentation imaging)
   4. Hunt and Hess 1-3 or World Federation of Neurosurgeons grade 1-4 (on screening, included only if also fulfilling Glasgow Coma Scale verbal subscore ≥4)
   5. Minimum Glasgow Coma Scale verbal subscore of 4 (on screening)

6. Able to verbalize pain scale scores according to 11-point numeric pain scale

   In order to be enrolled and undergo randomization in this study, an individual must meet all of the additional criteria:

7. Stabilization period criteria:

   1. A minimum of 4 hours from DSA with clipping or coiling procedure (whenever applicable)
   2. Successful treatment of culprit vascular lesion (i.e., ≥90% obliteration of aneurysm), when applicable

8. Requiring a minimum of 15mg OME prn for headache analgesia during any 24-hour period during eligibility period

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Premorbid conditions:

   • Pre-existing neurologic, psychiatric, or other condition that would confound neurologic assessment or would make difficult/impossible to accurately assess neurologic and/or functional outcome
   • Pre-existing diffuse flow-limiting narrowing of arteries in the Circle of Willis, regardless of etiology (e.g., atherosclerosis, vasculitis, Moya-Moya syndrome)
   • Prior use of opioid or barbiturate analgesics for at least two-thirds of the days in previous month, regardless of indication
   • Diagnosis of substance use disorder in the previous year
   • Infected or wounded skin, or a skin lesion at the site of puncture for PPF- injection

2. Uncorrected coagulopathy

   • Platelet count < 50,000/μL, International Normalized Ratio (INR) > 1.7
   • Requiring use of systemic anticoagulation and antiplatelet therapy (except for aspirin monotherapy).

3. SAH-specific:

   • Head trauma as etiology of SAH
   • Infection as cause for aneurysm or SAH (i.e., mycotic aneurysms)
   • Inability to successfully treat culprit vascular lesion
   • Diffuse vasospasm on initial diagnostic CTA or DSA. Vasospasm is defined as moderate-to-severe arterial narrowing on DSA or CTA not attributable to atherosclerosis, catheter-induced spasm, or vessel hypoplasia, as determined by a neuroradiologist or neurointerventionalist

4. Standard pain regimen conditions

   • Elevation of hepatic enzymes prohibiting use of scheduled APAP (i.e., AST or ALT > 3x upper limit level)
   • Chronic liver condition with absolute contra-indication for APAP (even at lower maximum daily doses)

5. Participation in a concurrent investigational/interventional study (observational studies allowed)

6. Known to be pregnant, or with a positive pregnancy test

7. Allergy or intolerance to the medications used in the PPF-block (i.e., ropivacaine, dexamethasone) or standard pain regimen (APAP)

8. Vulnerable populations such as prisoners and inmates (abiding GCP per the study IRB)

9. Unable to receive first PPF-injection within 96 hours of ictus hemorrhage

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Group 2 - Placebo - Active	Placebo Pteryogpalatine Fossa Injection	Subjects randomized to Group 2 will receive a placebo PPF-injection in Stage 1 followed by an active PPF nerve block in Stage 2 of the Double-Blinded Trial Phase
Group 1 - Active - Active	Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone	Subjects randomized to Group 1 will receive an active PPF nerve block in Stage 1 followed by an active PPF nerve block in Stage 2 of the Double-Blinded Trial Phase
Group 2 - Placebo - Active	Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone	Subjects randomized to Group 2 will receive a placebo PPF-injection in Stage 1 followed by an active PPF nerve block in Stage 2 of the Double-Blinded Trial Phase
Group 3 - Placebo - Placebo	Placebo Pteryogpalatine Fossa Injection	Subjects randomized to Group 3 will receive a placebo PPF-injection in Stage 1 followed by a placebo PPF-injection in Stage 2 of the Double-Blinded Trial Phase

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint	at 48 hours from first PPF-injection (end of double-blinded treatment period)	incidence of radiographic vasospasm
Primary Tolerability Endpoint	at 24 hours following the first PPF-injection	rate of acceptance of second PPF-injection
Primary Efficacy Endpoint	within 24 hours after each PPF-injection spanning the 48 hours of double-blinded treatment period	prn oral morphine equivalent (OME)/day use

Trial Locations

Locations (12)

Mayo Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Albany Medical College; 🇺🇸 Albany, New York, United States

University of Rochester Medical College; 🇺🇸 Rochester, New York, United States

Oregon Health and Sciences University; 🇺🇸 Portland, Oregon, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

University of Washington; 🇺🇸 Seattle, Washington, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States