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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetaminophen | Active Comparator | acetaminophen (1000 mg) - is self-administered at home on an empty stomach approximately 1-6 hours prior to the procedure. |
|
| Suzetrigine | Experimental | Suzetrigine (100mg) - is self-administered at home on an empty stomach approximately 1-6 hours prior to the procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suzetrigine | Drug | 100mg - Medication is self-administered at home on an empty stomach approximately 1-6 hours prior to the procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual 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). | 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). | 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). | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Hour 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wendy Jenkins, BSN RN, CCRC | Contact | 336.716.3842 | Wendy.Jenkins@AdvocateHealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Stephen B Tatter, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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After study consent is obtained. Subjects will be randomized to one of two arms. Each arm contains a medication currently being used in stereotactic frame placement. Arm 1 will be Acetaminophen and Arm 2 will be Suzetrigine.
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Both suzetrigine and acetaminophen will be placed into identical opaque capsules. Suzetrigine capsules will be backfilled with an inert excipient to match the weight and sound of the acetaminophen capsules.
| acetaminophen | Drug | 1000mg - Medication is self-administered at home on an empty stomach approximately 1-6 hours prior to the procedure. |
|
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| Hour 24 |
| Total Anesthetic Volume | Documentation of the total volume (mL) of local anesthetic infused. | Hour 6 |
| Aniline Compounds |
| D000588 | Amines |