Suzetrigine for Opioid-Free Recovery After Cesarean Delivery

NCT07534709 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: STUDY00008784
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Cesarean Delivery; Cesarean Section; Pain, Postoperative; Opioid Consumption, Postoperative

Keywords

suzetrigine; Cesarean Delivery; cesarean section; postoperative pain; opioid-free recovery; opioid-sparing; multimodal analgesia; postpartum opioid use; NaV1.8 Inhibitor

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Remaining Opioid-Free Through 72 Hours Postoperatively

  Proportion of participants who do not receive any opioid medications from completion of cesarean delivery through 72 hours postoperatively.

  From completion of surgery to 72 hours postoperatively

Secondary Outcomes (6)

• Postoperative Pain Intensity Scores

  During hospitalization through 72 hours postoperatively

• Maternal Satisfaction With Pain Management

  At hospital discharge and postoperative day 14

• Functional Recovery After Cesarean Delivery

  Postoperative day 7

• Post-Discharge Opioid Use

  From hospital discharge through postoperative day 14

• Study Drug Adherence (Proportion of Prescribed Study Medication Doses Taken)

  During hospitalization through postoperative day 7

Study Arms (2)

Suzetrigine

EXPERIMENTAL

Participants will receive oral suzetrigine following cesarean delivery in addition to standardized multimodal postoperative analgesia, including scheduled acetaminophen and nonsteroidal anti-inflammatory drugs, with opioid medications available as needed for breakthrough pain.

Drug: Suzetrigine

Placebo

EXPERIMENTAL

Participants will receive matching oral placebo following cesarean delivery in addition to standardized multimodal postoperative analgesia, including scheduled acetaminophen and nonsteroidal anti-inflammatory drugs, with opioid medications available as needed for breakthrough pain.

Drug: Placebo

Interventions

Suzetrigine DRUG

Oral suzetrigine administered following cesarean delivery as an adjunct to standardized multimodal postoperative analgesia, including scheduled acetaminophen and nonsteroidal anti-inflammatory drugs, with opioid medications available as needed for breakthrough pain.

Suzetrigine

Placebo DRUG

Matching oral placebo administered following cesarean delivery in addition to standardized multimodal postoperative analgesia, including scheduled acetaminophen and nonsteroidal anti-inflammatory drugs, with opioid medications available as needed for breakthrough pain.

Placebo

Eligibility Criteria

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

You may qualify if:

• Women aged ≥18 years.
• Undergoing scheduled or unscheduled cesarean delivery during the current admission, with or without concomitant salpingectomy.
• Planned delivery under neuraxial anesthesia (spinal, epidural, or combined spinal-epidural).
• Planned Pfannenstiel skin incision.
• Able to provide informed consent in English or Spanish.
• Willing and able to complete required remote follow-up assessments through postoperative day 14 (POD14).

You may not qualify if:

• Planned provision of breast milk to the neonate during the period of suzetrigine exposure (while the study drug is being taken and for 96 hours after last dose), due to the absence of human lactation safety data for suzetrigine.\*
• Known allergy, hypersensitivity, or contraindication to suzetrigine or any component of its formulation.
• Chronic opioid use, defined as daily opioid use for more than 7 consecutive days in the month prior to delivery, or current treatment for opioid use disorder.
• Significant hepatic disease, defined as AST or ALT \>3 times the upper limit of normal or Child-Pugh class B or C.
• Severe renal impairment, defined as estimated glomerular filtration rate (eGFR) \<15 mL/min.
• Concurrent use of medications known to significantly alter suzetrigine metabolism, including strong CYP3A inhibitors or inducers, such as:
• ketoconazole
• ritonavir
• carbamazepine
• rifampin
• St. John's wort (or other agents deemed clinically significant CYP3A modulators by the study investigator team)
• Planned cesarean delivery under general anesthesia without neuraxial anesthesia.
• Planned non-Pfannenstiel skin incision (e.g., vertical midline incision).
• Participation in another interventional pain-management clinical trial during the current hospitalization.
• Additional operative procedures (excluding salpingectomy) performed at the time of cesarean delivery (e.g., hysterectomy, hernia repair).

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

University of Texas at Austin Dell Medical School, Department of Women's Health

Austin, Texas, 78705, United States

Location

Related Publications (17)

• 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.

  PMID: 34014182 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.

  PMID: 34445918 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.

  PMID: 33078388 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.

  PMID: 35659962 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.

  PMID: 40117446 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.

  PMID: 37530822 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.

  PMID: 28625307 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.

  PMID: 40335351 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.

  PMID: 28219963 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.

  PMID: 28594766 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.

  PMID: 32217114 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.

  PMID: 26996986 BACKGROUND

• ACOG Committee Opinion No. 742: Postpartum Pain Management. Obstet Gynecol. 2018 Jul;132(1):e35-e43. doi: 10.1097/AOG.0000000000002683.

  PMID: 29781876 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.

  PMID: 28594762 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.

  PMID: 34412076 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.

  PMID: 31348508 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.

  PMID: 40961109 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Lorie M. Harper, MD, MSCI

  Dell Medical School, University of Texas at Austin, Department of Women's Health

  STUDY DIRECTOR

Central Study Contacts

Chase Calvert, MD

CONTACT

512-771-0773; calvertchase@utexas.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: This study is double-blind, with participants and clinical care providers masked to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maternal-Fetal Medicine Division Chief, Professor

Model Details: Participants will be randomized in a 1:1 ratio to one of two parallel groups (suzetrigine or placebo) for the duration of the study. Randomization will be performed using a computer-generated allocation sequence with variable block sizes and allocation concealment.

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 16, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)