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NCT Number: NCT07525219

Suzetrigine Frame Trial Comparing Suzetrigine and Acetaminophen

Local anesthetic infiltration is a primary source of acute pain during stereotactic procedures.

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Key information

Conditions

Analgesic Efficacy

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location status: Recruiting

Location contact

Wendy Jenkins, BSN RN, CCRC

CONTACT

[email protected]

336-716-3842

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Suzetrigine

Drug

100mg - Medication is self-administered at home on an empty stomach approximately 1-6 hours prior to the procedure.

Other names: Journavx

Acetaminophen

Drug

1000mg - Medication is self-administered at home on an empty stomach approximately 1-6 hours prior to the procedure.

Other names: Tylenol

Primary outcomes

  1. Visual Analog Scale (VAS-Anxiety) score

    Time frame: 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).

  2. Visual Analog Scale (VAS-Infiltration) score

    Time frame: 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).

  3. Visual Analog Scale (VAS-Pin Tightening) score

    Time frame: 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).

  4. Visual Analog Scale (VAS-Anxiety Reassessment) score

    Time frame: 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).

  5. Total Anesthetic Volume

    Time frame: Hour 6

    Documentation of the total volume (mL) of local anesthetic infused.

Secondary outcomes

  1. Number of Clinically Significant Vasovagal Episodes

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Wendy Jenkins, BSN RN, CCRC

CONTACT

[email protected]

336.716.3842

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

A Randomized Controlled Trial Comparing Suzetrigine and Acetaminophen for Reducing Pain During Local Anesthetic Infiltration and Head Frame Application

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 13, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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