Pterygopalatine Fossa Treatment for Acute Headache in Aneurysmal

Overview

About this study

The purpose of this study is to assess the efficacy and safety of PPF-block to mitigate opiod use requirements and improve headache pain control in patients with aneurysmal SAH.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Provision of signed and dated informed consent form.
  • 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, subarachnoid hemorrhage within 48 hours of ictus hemorrhage.
  • Disease-specific inclusion criteria:
    • Aneurysm identified as culprit of SAH;
    • Modified Fisher grade 1-4 (on admission 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:
      • Between 4-48 hours from clipping or coiling procedure (whichever applicable);
      • Successful treatment of culprit vascular lesion (i.e., ≥ 90% obliteration of aneurysm).
    • Requiring a minimum of 15mg OME prn during the 24-hour period immediately prior to enrollment.

Exclusion Criteria:

  • 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;
    • 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 o Infected or wounded skin, or a skin lesion at the site of puncture for PPF-injection.
  • Uncorrected coagulopathy:
    • platelet count < 50,000/μL, INR > 1.7;
    • requiring use of systemic anticoagulation, ticagrelor or dual antiplatelet therapy.
  • 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 angiography (vasospasm defined as: moderate-tosevere arterial narrowing on digital subtraction angiography 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 acetaminophen (i.e., AST or ALT > 3 x upper limit level);
    • Chronic liver condition with absolute contra-indication for acetaminophen (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 7. Allergy or intolerance to the medications used in the PPF-block (i.e., ropivacaine, dexamethasone) or standard pain regimen (acetaminophen).

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 7/17/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Narayan Kissoon, M.D.

Open for enrollment

Contact information:

Bridget Neja C.N.A.

(507) 266-9150

Neja.Bridget@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

William Freeman, M.D.

Open for enrollment

Contact information:

Amber Patchell

(904) 953-6384

Patchell.Amber@mayo.edu

More information

Publications

Publications are currently not available