Suzetrigine Following Urogynecologic Surgery: Investigation of Postoperative Pain Management

Summary

The goal of this clinical trial is to determine whether suzetrigine, when added to standardized multimodal postoperative analgesia improves pain control and reduces opioid consumption after apical suspension surgery for pelvic organ prolapse. Researchers will compare suzetrigine to a placebo (a look-alike substance that contains no drug) to evaluate this outcome. The main questions it aims to answer are: * Does suzetrigine reduce postoperative pain scores compared to placebo? * Does suzetrigine reduce the need for opioid rescue medication after surgery? Researchers will compare participants receiving suzetrigine to participants receiving placebo, both on top of standard postoperative pain management, to see if suzetrigine lowers pain scores and opioid consumption after apical suspension surgery.

Timeline

Start

2026-11

Primary completion

2027-12

Completion

2028-05

Publications

• Background Jones J, Correll DJ, Lechner SM, Jazic I, Miao X, Shaw D, Simard C, Osteen JD, Hare B, Beaton A, Bertoch T, Buvanendran A, Habib AS, Pizzi LJ, Pollak RA, Weiner SG, Bozic C, Negulescu P, White PF; VX21-548-101 and VX21-548-102 Trial Groups. Selective Inhibition of NaV1.8 with VX-548 for Acute Pain. N Engl J Med. 2023 Aug 3;389(5):393-405. doi: 10.1056/NEJMoa2209870.
• Background Myles PS, Myles DB, Galagher W, Boyd D, Chew C, MacDonald N, Dennis A. Measuring acute postoperative pain using the visual analog scale: the minimal clinically important difference and patient acceptable symptom state. Br J Anaesth. 2017 Mar 1;118(3):424-429. doi: 10.1093/bja/aew466.
• Background Bertoch T, D'Aunno D, McCoun J, Solanki D, Taber L, Urban J, Oswald J, Swisher MW, Tian S, Miao X, Correll DJ, Negulescu P, Bozic C, Weiner SG. Suzetrigine, a Nonopioid Na V 1.8 Inhibitor for Treatment of Moderate-to-severe Acute Pain: Two Phase 3 Randomized Clinical Trials. Anesthesiology. 2025 Jun 1;142(6):1085-1099. doi: 10.1097/ALN.0000000000005460. Epub 2025 Mar 21.
• Background Nilsson W, Narwold E, Turner L, Shepherd J. Comparing Post-Operative Pain Outcomes in Pelvic Organ Prolapse Surgery With and Without a Hysterectomy. Int Urogynecol J. 2025 Aug;36(8):1649-1654. doi: 10.1007/s00192-025-06162-6. Epub 2025 May 10.
• Background Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R. CDC Clinical Practice Guideline for Prescribing Opioids for Pain - United States, 2022. MMWR Recomm Rep. 2022 Nov 4;71(3):1-95. doi: 10.15585/mmwr.rr7103a1.
• Background By the 2023 American Geriatrics Society Beers Criteria(R) Update Expert Panel. American Geriatrics Society 2023 updated AGS Beers Criteria(R) for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2023 Jul;71(7):2052-2081. doi: 10.1111/jgs.18372. Epub 2023 May 4.
• Background Willis-Gray MG, Young JC, Pate V, Jonsson Funk M, Wu JM. Perioperative opioid prescriptions associated with stress incontinence and pelvic organ prolapse surgery. Am J Obstet Gynecol. 2020 Dec;223(6):894.e1-894.e9. doi: 10.1016/j.ajog.2020.07.004. Epub 2020 Jul 9.
• Background Agrawal P, Choi U, Liao B, Kohn TP, Kohn J, Dumas K, Clifton M. Perioperative Pain Management With Opioid Analgesics in Colpopexy Increases Risk of New Persistent Opioid Usage. Urogynecology (Phila). 2023 Feb 1;29(2):183-190. doi: 10.1097/SPV.0000000000001305.
• Background Swenson CW, Kamdar NS, Seiler K, Morgan DM, Lin P, As-Sanie S. Definition development and prevalence of new persistent opioid use following hysterectomy. Am J Obstet Gynecol. 2018 Nov;219(5):486.e1-486.e7. doi: 10.1016/j.ajog.2018.06.010. Epub 2018 Jun 19.
• Background AlAshqar A, Ishiwata R, Moss C, Andersen KM, Yanek L, Bicket MC, Alexander GC, Borahay MA. Predictors of new persistent opioid use after benign hysterectomy in the United States. Am J Obstet Gynecol. 2022 Jul;227(1):68.e1-68.e24. doi: 10.1016/j.ajog.2022.02.030. Epub 2022 Mar 3.
• Background Wright JD, Huang Y, Melamed A, Tergas AI, St Clair CM, Hou JY, Khoury-Collado F, Ananth CV, Neugut AI, Hershman DL. Use and Misuse of Opioids After Gynecologic Surgical Procedures. Obstet Gynecol. 2019 Aug;134(2):250-260. doi: 10.1097/AOG.0000000000003358.
• Background Selle JM, Strozza DM, Branda ME, Gebhart JB, Trabuco EC, Occhino JA, Linder BJ, El Nashar SA, Madsen AM. A bundle of opioid-sparing strategies to eliminate routine opioid prescribing in a urogynecology practice. Am J Obstet Gynecol. 2024 Aug;231(2):278.e1-278.e17. doi: 10.1016/j.ajog.2024.05.043. Epub 2024 May 25.
• Background Reagan KML, O'Sullivan DM, Gannon R, Steinberg AC. Decreasing postoperative narcotics in reconstructive pelvic surgery: a randomized controlled trial. Am J Obstet Gynecol. 2017 Sep;217(3):325.e1-325.e10. doi: 10.1016/j.ajog.2017.05.041. Epub 2017 May 25.
• Background Yuan AS, Propst KA, Ross JH, Wallace SL, Paraiso MFR, Park AJ, Chapman GC, Ferrando CA. Restrictive opioid prescribing after surgery for prolapse and incontinence: a randomized, noninferiority trial. Am J Obstet Gynecol. 2024 Mar;230(3):340.e1-340.e13. doi: 10.1016/j.ajog.2023.10.027. Epub 2023 Oct 18.
• Background Petrikovets A, Sheyn D, Sun HH, Chapman GC, Mahajan ST, Pollard RR, El-Nashar SA, Hijaz AK, Mangel J. Multimodal opioid-sparing postoperative pain regimen compared with the standard postoperative pain regimen in vaginal pelvic reconstructive surgery: a multicenter randomized controlled trial. Am J Obstet Gynecol. 2019 Nov;221(5):511.e1-511.e10. doi: 10.1016/j.ajog.2019.06.002. Epub 2019 Jun 12.
• Background Ramaseshan AS, O'Sullivan DM, Steinberg AC, Tunitsky-Bitton E. A comprehensive model for pain management in patients undergoing pelvic reconstructive surgery: a prospective clinical practice study. Am J Obstet Gynecol. 2020 Aug;223(2):262.e1-262.e8. doi: 10.1016/j.ajog.2020.05.019. Epub 2020 May 13.
• Background Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, Haythornthwaite JA, Jensen MP, Kerns RD, Ader DN, Brandenburg N, Burke LB, Cella D, Chandler J, Cowan P, Dimitrova R, Dionne R, Hertz S, Jadad AR, Katz NP, Kehlet H, Kramer LD, Manning DC, McCormick C, McDermott MP, McQuay HJ, Patel S, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Revicki DA, Rothman M, Schmader KE, Stacey BR, Stauffer JW, von Stein T, White RE, Witter J, Zavisic S. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008 Feb;9(2):105-21. doi: 10.1016/j.jpain.2007.09.005. Epub 2007 Dec 11.
• Background Linder BJ, Occhino JA, Wiest SR, Klingele CJ, Trabuco EC, Gebhart JB. Assessing the impact of procedure-specific opioid prescribing recommendations on opioid stewardship following pelvic organ prolapse surgery. Am J Obstet Gynecol. 2019 Nov;221(5):515.e1-515.e8. doi: 10.1016/j.ajog.2019.06.023. Epub 2019 Jun 18.
• Background ACOG Committee Opinion No. 750: Perioperative Pathways: Enhanced Recovery After Surgery. Obstet Gynecol. 2018 Sep;132(3):e120-e130. doi: 10.1097/AOG.0000000000002818.
• Background Rogers RG, Leeman LL. Postpartum genitourinary changes. Urol Clin North Am. 2007 Feb;34(1):13-21. doi: 10.1016/j.ucl.2006.10.005.

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