Analgesic Efficacy
Conditions
Keywords
procedural prophylaxis, anesthetic infiltration, stereotactic head frame
Brief summary
Local anesthetic infiltration is a primary source of acute pain during stereotactic procedures.
Detailed description
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.
Interventions
DRUGSuzetrigine
100mg - Medication is self-administered at home on an empty stomach approximately 1-6 hours prior to the procedure.
DRUGacetaminophen
1000mg - Medication is self-administered at home on an empty stomach approximately 1-6 hours prior to the procedure.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for a standard of care procedure requiring a stereotactic head frame to be placed
Exclusion criteria
* Patients not scheduled for a standard of care procedure requiring a stereotactic head frame to be placed will not be approached
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS-Anxiety) score | Baseline | 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). |
| Visual Analog Scale (VAS-Infiltration) score | Baseline | 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). |
| Visual Analog Scale (VAS-Pin Tightening) score | Baseline | 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). |
| Visual Analog Scale (VAS-Anxiety Reassessment) score | Hour 24 | 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). |
| Total Anesthetic Volume | Hour 6 | Documentation of the total volume (mL) of local anesthetic infused. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Clinically Significant Vasovagal Episodes | Hour 6 | 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. |
Countries
United States
Contacts
CONTACTWendy Jenkins, BSN RN, CCRC
PRINCIPAL_INVESTIGATORStephen B Tatter, MD
Wake Forest University Health Sciences
Outcome results
None listed