drugset / Trial / NCT07463430
Suzetrigine for Non-Mastectomy Breast Surgery
Phase 4
Enrolling by invitation
120 enrolled
University of California, San Diego
Vertex Pharmaceuticals Incorporated · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2026-04-14
- Primary completion
- 2027-12-28
- Completion
- 2027-12-31
Publications
- Background 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Suzetrigine | Small molecule | 50 mg | Oral |