Recruiting
Phase 3

Local Anesthetic

Sponsor:

Wake Forest University Health Sciences

Code:

NCT07525219

Conditions

Analgesic Efficacy

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Suzetrigine

acetaminophen

Study Details

Brief summary:

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

Conditions

Analgesic Efficacy

Study ID

NCT07525219

Start date

Jun 22, 2026

Status verified date

Apr, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Acetaminophen

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

experimental: Suzetrigine

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

Interventions

Suzetrigine

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

acetaminophen

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

Primary outcome measure

  • Visual Analog Scale (VAS-Anxiety) score [ Time Frame: Baseline ]
  • Visual Analog Scale (VAS-Infiltration) score [ Time Frame: Baseline ]
  • Visual Analog Scale (VAS-Pin Tightening) score [ Time Frame: Baseline ]
  • Visual Analog Scale (VAS-Anxiety Reassessment) score [ Time Frame: Hour 24 ]
  • Total Anesthetic Volume [ Time Frame: Hour 6 ]

Central Contacts and Locations

Central contacts

Wendy Jenkins, BSN RN, CCRC

336.716.3842Wendy.Jenkins@AdvocateHealth.org

Locations

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Wendy Jenkins, BSN RN, CCRC

336-716-3842Wendy.Jenkins@Advocatehealth.org

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jul 28, 2026

Last verified

Apr, 2026

Keywords

  • procedural prophylaxis
  • anesthetic infiltration
  • stereotactic head frame

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-07-28.