Suzetrigine for Non-Mastectomy Breast Surgery

NCT07463430 | Enrolling By Invitation Phase 4 FDA Drug

• 1 other identifier: Suzetrigine
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Disease; Pain, Acute Postoperative

Outcome Measures

Primary Outcomes (1)

• Worst pain level first 3 postoperative days

  The numeric rating scale (NRS) is a highly-sensitive measure of pain intensity with numbers ranging from 0 to 10, zero equivalent to no pain and 10 equivalent to the worst imaginable pain. The primary outcome measure will be the median value of each participant's worst daily NRS collected on postoperative days 1, 2, and 3 (both the active treatment and historic controls).

  postoperative days 1-3

Secondary Outcomes (13)

• Daily worst/maximum pain

  postoperative days 1-5 and 7; and 6 months following surgery

• Average NRS evaluated on postoperative day 2

  postoperative days 1-5 and 7; and 6 months following surgery

• Least (lowest) NRS evaluated on postoperative day 2

  postoperative day 2

• Current NRS evaluated on postoperative day 2

  postoperative day 2

• Brief Pain Inventory, short form (Interference Subscale)

  postoperative day 2

Study Arms (1)

Experimental: Suzetrigine

EXPERIMENTAL

Preoperatively, participants will be administered suzetrigine 100 mg orally. Postoperative study medication will consist of 5 tablets of suzetrigine 50 mg. Participants will be instructed to take 1 tablet every 12 hours following the initial dose through the evening of postoperative day 2.

Drug: suzetrigine

Interventions

suzetrigine DRUG

A total of seven 50 mg tablets of suzetrigine administered preoperatively.

Also known as: Journavx

Experimental: Suzetrigine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• Pregnancy
• Inability to contact the investigators during the treatment period, and vice versa (e.g., lack of telephone access)

Sponsors & Collaborators

• University of California, San Diego: lead
• Vertex Pharmaceuticals Incorporated: collaborator

Study Sites (1)

University of California San Diego

San Diego, California, 92103, United States

Location

Related Publications (7)

• Ilfeld BM, Abramson WB, Said ET, Sztain JF, Finneran JJ 4th, Griggs JL, Abdullah B, Jensen EJ, Schaar A, Wallace AM. Percutaneous auricular neuromodulation to treat pain after ambulatory breast surgery: A randomized, double-masked, sham-controlled pilot study. Can J Pain. 2025 Jul 10;9(1):2521117. doi: 10.1080/24740527.2025.2521117. eCollection 2025.

  PMID: 40657450 BACKGROUND

• Ilfeld BM, Finneran JJ 4th, Said ET, Ball ST, Wallace AM, Broderick RC, Sandler BJ, Doucet JJ, Hu SR, Cha BJ, Murthy AN, Abdullah B. Wearable, noninvasive, pulsed shortwave (radiofrequency) therapy for postoperative analgesia: A randomized, double-masked, sham-controlled pilot study. Pain Pract. 2025 Feb;25(2):e70007. doi: 10.1111/papr.70007.

  PMID: 39829429 BACKGROUND

• Farrar JT, Berlin JA, Strom BL. Clinically important changes in acute pain outcome measures: a validation study. J Pain Symptom Manage. 2003 May;25(5):406-11. doi: 10.1016/s0885-3924(03)00162-3.

  PMID: 12727037 BACKGROUND

• Dworkin RH, Turk DC, McDermott MP, Peirce-Sandner S, Burke LB, Cowan P, Farrar JT, Hertz S, Raja SN, Rappaport BA, Rauschkolb C, Sampaio C. Interpreting the clinical importance of group differences in chronic pain clinical trials: IMMPACT recommendations. Pain. 2009 Dec;146(3):238-244. doi: 10.1016/j.pain.2009.08.019.

  PMID: 19836888 BACKGROUND

• Ilfeld BM. Why science is less scientific than we think (and what to do about it): The 2022 Gaston Labat Award Lecture. Reg Anesth Pain Med. 2022 Jul;47(7):395-400. doi: 10.1136/rapm-2021-103331. Epub 2022 Apr 1. No abstract available.

  PMID: 35365548 BACKGROUND

• Schober P, Vetter TR. Correct Baseline Comparisons in a Randomized Trial. Anesth Analg. 2019 Sep;129(3):639. doi: 10.1213/ANE.0000000000004211. No abstract available.

  PMID: 31425197 BACKGROUND

• Mascha EJ, Turan A. Joint hypothesis testing and gatekeeping procedures for studies with multiple endpoints. Anesth Analg. 2012 Jun;114(6):1304-17. doi: 10.1213/ANE.0b013e3182504435. Epub 2012 May 3.

  PMID: 22556210 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Breast Diseases

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Brian M Ilfeld, MD, MS

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, In Residence

Model Details: Series of unmasked participants receiving active treatment who will subsequently be compared with a historic control group.

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 11, 2026
• Study Start: April 14, 2026
• Primary Completion (Estimated): December 28, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Following publication of the primary analysis in a peer-reviewed journal for a period of 5 years.

Locations

US (1)