Suzetrigine for Opioid-Free Recovery After Cesarean Delivery

Summary

The goal of this clinical trial is to determine whether suzetrigine increases the proportion of patients who remain completely opioid-free from completion of surgery through 72 hours after cesarean delivery. The main question it aims to answer is: Does adjunctive suzetrigine, when added to a standardized multimodal postoperative analgesic regimen, increase the proportion of patients who remain opioid-free during the first 72 hours after cesarean delivery? Researchers will compare suzetrigine to a placebo (a look-alike substance that contains no drug) to evaluate this outcome. Participants will: * Receive either suzetrigine or placebo after cesarean delivery * Receive standard postoperative pain management, including acetaminophen, nonsteroidal anti-inflammatory drugs, and neuraxial morphine * Have opioid medications available as needed for breakthrough pain * Be followed during hospitalization and after discharge to assess pain, recovery, and medication use

Timeline

Start

2026-06

Primary completion

2028-02

Completion

2028-05

Publications

• Background Reed SE, Tan HS, Fuller ME, Krishnamoorthy V, Ohnuma T, Raghunathan K, Habib AS. Analgesia After Cesarean Delivery in the United States 2008-2018: A Retrospective Cohort Study. Anesth Analg. 2021 Dec 1;133(6):1550-1558. doi: 10.1213/ANE.0000000000005587.
• Background Meyer MF, Broman AT, Gnadt SE, Sharma S, Antony KM. A standardized post-cesarean analgesia regimen reduces postpartum opioid use. J Matern Fetal Neonatal Med. 2022 Dec;35(25):8267-8274. doi: 10.1080/14767058.2021.1970132. Epub 2021 Aug 26.
• Background Deussen AR, Ashwood P, Martis R, Stewart F, Grzeskowiak LE. Relief of pain due to uterine cramping/involution after birth. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD004908. doi: 10.1002/14651858.CD004908.pub3.
• Background Veef E, Van de Velde M. Post-cesarean section analgesia. Best Pract Res Clin Anaesthesiol. 2022 May;36(1):83-88. doi: 10.1016/j.bpa.2022.02.006. Epub 2022 Apr 10.
• 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 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 Carvalho B, Butwick AJ. Postcesarean delivery analgesia. Best Pract Res Clin Anaesthesiol. 2017 Mar;31(1):69-79. doi: 10.1016/j.bpa.2017.01.003. Epub 2017 Jan 12.
• Background Sultan P, Monks DT, Sharawi N, Bamber J, Panelli DM, Sauro KM, Shah PS, Muraca GM, Metcalfe A, Wood SL, Jago CA, Daly S, Blake LEA, Macones GA, Caughey AB, Wilson RD, Nelson G. Guidelines for postoperative care in cesarean delivery: Enhanced Recovery After Surgery Society recommendations (part 3)-2025 update. Am J Obstet Gynecol. 2026 Jan;233(6S):S184-S198. doi: 10.1016/j.ajog.2025.01.038. Epub 2025 Apr 28.
• Background Finkelstein Y, Macdonald EM, Gonzalez A, Sivilotti MLA, Mamdani MM, Juurlink DN; Canadian Drug Safety And Effectiveness Research Network (CDSERN). Overdose Risk in Young Children of Women Prescribed Opioids. Pediatrics. 2017 Mar;139(3):e20162887. doi: 10.1542/peds.2016-2887. Epub 2017 Feb 20.
• Background Osmundson SS, Schornack LA, Grasch JL, Zuckerwise LC, Young JL, Richardson MG. Postdischarge Opioid Use After Cesarean Delivery. Obstet Gynecol. 2017 Jul;130(1):36-41. doi: 10.1097/AOG.0000000000002095.
• Background Peahl AF, Morgan DM, Dalton VK, Zivin K, Lai YL, Hu HM, Langen E, Low LK, Brummett CM, Waljee JF, Bauer ME. New persistent opioid use after acute opioid prescribing in pregnancy: a nationwide analysis. Am J Obstet Gynecol. 2020 Oct;223(4):566.e1-566.e13. doi: 10.1016/j.ajog.2020.03.020. Epub 2020 Mar 23.
• Background Bateman BT, Franklin JM, Bykov K, Avorn J, Shrank WH, Brennan TA, Landon JE, Rathmell JP, Huybrechts KF, Fischer MA, Choudhry NK. Persistent opioid use following cesarean delivery: patterns and predictors among opioid-naive women. Am J Obstet Gynecol. 2016 Sep;215(3):353.e1-353.e18. doi: 10.1016/j.ajog.2016.03.016. Epub 2016 Mar 17.
• Background ACOG Committee Opinion No. 742: Postpartum Pain Management. Obstet Gynecol. 2018 Jul;132(1):e35-e43. doi: 10.1097/AOG.0000000000002683.
• Background Prabhu M, McQuaid-Hanson E, Hopp S, Burns SM, Leffert LR, Landau R, Lauffenburger JC, Choudhry NK, Kaimal A, Bateman BT. A Shared Decision-Making Intervention to Guide Opioid Prescribing After Cesarean Delivery. Obstet Gynecol. 2017 Jul;130(1):42-46. doi: 10.1097/AOG.0000000000002094.
• Background Pharmacologic Stepwise Multimodal Approach for Postpartum Pain Management: ACOG Clinical Consensus No. 1. Obstet Gynecol. 2021 Sep 1;138(3):507-517. doi: 10.1097/AOG.0000000000004517.
• Background Peahl AF, Dalton VK, Montgomery JR, Lai YL, Hu HM, Waljee JF. Rates of New Persistent Opioid Use After Vaginal or Cesarean Birth Among US Women. JAMA Netw Open. 2019 Jul 3;2(7):e197863. doi: 10.1001/jamanetworkopen.2019.7863.
• Background Osterman MJK, Hamilton BE, Martin JA, Driscoll AK, Valenzuela CP. Births: Final Data for 2023. Natl Vital Stat Rep. 2025 Mar 18;(1):1. doi: 10.15620/cdc/175204.

Drugs

Indications

No indication recorded.