Local anesthetic infiltration is a primary source of acute pain during stereotactic procedures.
Frame placement can be painful even with local numbing medicine. This study compares two oral medications-Suzetrigine (an FDA-approved (January 30, 2025) non-opioid, non-addictive medication used to treat moderate-to-severe acute pain in adults)) and acetaminophen (Tylenol)-to see which is more effective at reducing this pain. Both Tylenol and Suzetrigine are currently being used for pain prevention during head frame placement. This study is being conducted to determine if one offers greater relief than the other.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
80
100mg - Medication is self-administered at home on an empty stomach approximately 1-6 hours prior to the procedure.
1000mg - Medication is self-administered at home on an empty stomach approximately 1-6 hours prior to the procedure.
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
RECRUITINGVisual Analog Scale (VAS-Anxiety) score
A single consolidated VAS score (0-10) representing the pain experienced during the administration of local anesthetic across all four pin sites. This VAS is administered immediately after the local anesthetic injections are completed. For anxiety-VAS cutoff value = 40: the VAS score is ≥40 in 81% of patients with anxiety (sensitivity); the VAS score is \<40 in 70% of patients without anxiety (specificity); 67% of patients with a VAS score ≥ 40 have anxiety (PPV); 82% of patients with a VAS score \<40 do not have anxiety (NPV).
Time frame: Baseline
Visual Analog Scale (VAS-Infiltration) score
A single consolidated VAS score (0-10) representing the pain experienced during the administration of local anesthetic across all four pin sites. This VAS is administered immediately after the local anesthetic injections are completed. For anxiety-VAS cutoff value = 40: the VAS score is ≥40 in 81% of patients with anxiety (sensitivity); the VAS score is \<40 in 70% of patients without anxiety (specificity); 67% of patients with a VAS score ≥ 40 have anxiety (PPV); 82% of patients with a VAS score \<40 do not have anxiety (NPV).
Time frame: Baseline
Visual Analog Scale (VAS-Pin Tightening) score
A single consolidated VAS score (0-10) representing the pain experienced during the administration of local anesthetic across all four pin sites. This VAS is administered immediately after the local anesthetic injections are completed. For anxiety-VAS cutoff value = 40: the VAS score is ≥40 in 81% of patients with anxiety (sensitivity); the VAS score is \<40 in 70% of patients without anxiety (specificity); 67% of patients with a VAS score ≥ 40 have anxiety (PPV); 82% of patients with a VAS score \<40 do not have anxiety (NPV).
Time frame: Baseline
Visual Analog Scale (VAS-Anxiety Reassessment) score
A single consolidated VAS score (0-10) representing the pain experienced during the administration of local anesthetic across all four pin sites. This VAS is administered immediately after the local anesthetic injections are completed. For anxiety-VAS cutoff value = 40: the VAS score is ≥40 in 81% of patients with anxiety (sensitivity); the VAS score is \<40 in 70% of patients without anxiety (specificity); 67% of patients with a VAS score ≥ 40 have anxiety (PPV); 82% of patients with a VAS score \<40 do not have anxiety (NPV).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Hour 24
Total Anesthetic Volume
Documentation of the total volume (mL) of local anesthetic infused.
Time frame: Hour 6
Number of Clinically Significant Vasovagal Episodes
Documentation of any vasovagal response characterized by loss of color, sweating, and/or nausea that requires rescue via raising the patient's legs to a height higher than their head.
Time frame: Hour 6