What this study is
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)
What's being tested
- Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone
Intervention · DRUG
Each PPF-active nerve block will consist of 20mg (4ml) ropivacaine plus 4mg (1ml) dexamethasone
- Placebo Pteryogpalatine Fossa Injection
Intervention · PROCEDURE
Each placebo PPF-injection will consist of 5ml normal saline
Study details
- Official title
- Pterygopalatine Fossa (PPF) Block as an Opioid Sparing Treatment for Acute Headache in Spontaneous Subarachnoid Hemorrhage
- Sponsor
- University of Florida
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal · Headache
- Enrolling
- 195 people
- Starts
- 2023-12-17
- Est. completion
- 2027-02-28
- Design
- Quadruple-blind, randomized, sequential groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 85 YearsSex ALLHealthy volunteers Not acceptedAll participants
You may qualify if
- Provision of signed and dated ICF by participant or a legally authorized representative (LAR)
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged ≥18 and ≤ 85 years
- Admitted with a primary diagnosis of spontaneous, non-traumatic, SAH within 72 hours of ictus hemorrhage
Disease-specific
You may qualify if
- Spontaneous, non-traumatic SAH
- 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
- Modified Fisher grade 1-4 (on presentation imaging)
- 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)
- Minimum Glasgow Coma Scale verbal subscore of 4 (on screening)
- 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:; Stabilization period criteria:; A minimum of 4 hours from DSA with clipping or coiling procedure (whenever applicable)
- Successful treatment of culprit vascular lesion (i.e., ≥90% obliteration of aneurysm), when applicable
- Requiring a minimum of 15mg OME prn for headache analgesia during any 24-hour period during eligibility period
You can't join if
- 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
- 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).
- 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 pre-enrollment 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
- 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)
- Participation in a concurrent investigational/interventional study (observational studies allowed)
- Known to be pregnant, or with a positive pregnancy test
- Allergy or intolerance to the medications used in the PPF-block (i.e., ropivacaine, dexamethasone) or standard pain regimen (APAP)
- Vulnerable populations such as prisoners and inmates (abiding GCP per the study IRB)
- Unable to receive first PPF-injection within 96 hours of ictus hemorrhage
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (13)
13 openUniversity of Florida
Gainesville, Florida, United States
- Carolina Maciel, MD MSCR · Contact352-273-5500carolina.maciel@neurology.ufl.edu
RecruitingUniversity of Miami
Miami, Florida, United States
- Ana Karen Bolaños · Contact305-243-3063axb2916@med.miami.edu
- Nina Massad, MD · Principal investigator
RecruitingCleveland Clinic Foundation Martin Health
Stuart, Florida, United States
- Irene Ball · Contact772-763-9317balli@ccf.org
- Marc Babi, MD · Principal investigator
RecruitingEmory University
Atlanta, Georgia, United States
- Christine Spainhour · Contact404-727-1558christine.spainhour@emory.edu
- Ofer Sadan, MD · Principal investigator
RecruitingUniversity of Maryland Baltimore
Baltimore, Maryland, United States
- David Oriko · Contact410-328-7822doriko@som.umaryland.edu
- Nicholas Morris, MD · Principal investigator
RecruitingCreighton University Medical Center
Omaha, Nebraska, United States
- Caroline Nubel · Contact402-280-4032CarolineNubel@creighton.edu
- Jason Lambrecht, MD · Principal investigator
RecruitingUniversity of Rochester Medical College
Rochester, New York, United States
- Tilor Hallquist · Contact585-275-3709Tilor_Hallquist@URMC.Rochester.edu
- Matthew Bender, MD · Principal investigator
RecruitingUniversity of North Carolina
Chapel Hill, North Carolina, United States
- Leyla Hatfield · Contact919-445-2620hatfieldl@neurology.unc.edu
- Lindsey Krawchuk, MD · Principal investigator
RecruitingUniversity of Cincinnati
Cincinnati, Ohio, United States
- Alexandra Ramirez · Contact513-558-0101ramiream@ucmail.uc.edu
- Charles Prestigiacomo, MD · Principal investigator
RecruitingOregon Health and Sciences University
Portland, Oregon, United States
- Sarah Feller · Contact503-494-6233fellersa@ohsu.edu
- Ines Koerner, MD · Principal investigator
RecruitingThomas Jefferson University
Philadelphia, Pennsylvania, United States
- Danna Smith · Contact215-955-2173danna.smith@jefferson.edu
- Stavropoula Tjoumakaris, MD · Principal investigator
Not yet recruitingUniversity of Washington
Seattle, Washington, United States
- Do Lim · Contact206-744-9389dolim@uw.edu
- Sarah Wahlster, MD · Principal investigator
RecruitingMedical College of Wisconsin
Milwaukee, Wisconsin, United States
- Jacob Labinski · Contact414-805-2578jlabinski@mcw.edu
- Tom Aufderheide, MD · Principal investigator
Recruiting
Study team
Sponsor
University of Florida
Study ID IRB CED000000829
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.