By InvitationPhase 4

Suzetrigine for Non-Mastectomy Breast Surgery

United States120 participantsStarted 2026-04-14

Plain-language summary

This is a single-center clinical study to investigate the efficacy of a Food and Drug Administration-approved analgesic, suzetrigine, to treat pain following non-mastectomy breast surgery in concert with a single-injection paravertebral nerve block.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Adult participants of at least 18 years of age
✓. Undergoing uni-or bilateral surgical procedures of the breast(s) anticipated to result in at least moderate pain (NRS \> 3)
✓. Planned single-injection peripheral nerve block(s)

Exclusion criteria

✕. Chronic opioid or tramadol use (daily within prior 2 weeks and duration \> 4 weeks)
✕. Neurological deficit of the surgical area
✕. History of opioid misuse or dependence
✕. Renal impairment with a GFR\<15
✕. Hepatic impairment (Child-Pugh Class B or C)
✕. Use of a moderate or strong CYP3A inhibitor in the week before or plan for use the week after surgery
✕. Current use of hormonal contraceptive containing progestins other than levonorgestrel and norethindrone, physiologic potential for pregnancy, anticipated sexual activity within the first postoperative month, and unwillingness to use additional nonhormonal contraception
✕. Incarceration

What they're measuring

Worst pain level first 3 postoperative days

Timeframe: postoperative days 1-3

Trial details

NCT IDNCT07463430

SponsorUniversity of California, San Diego

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-28

View on ClinicalTrials.gov More Pain, Acute Postoperative trials