Suzetrigine for Opioid-Sparing Postoperative Analgesia Following Transvaginal Pelvic Reconstructive Surgery

NCT07600697 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 26-0498
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Suzetrigine is a selective NaV1.8 inhibitor that provides peripheral analgesia without opioid-related CNS effects. This single-center stepped-wedge randomized clinical trial evaluates whether a suzetrigine-based postoperative analgesic regimen provides non-inferior pain control compared with standard opioid-inclusive care following transvaginal pelvic reconstructive surgery. The study will enroll 120 participants and assess pain, opioid consumption, adverse events, and functional recovery.

Conditions

Pelvic Organ Prolapse (POP); Stress Urinary Incontinence (SUI); Postoperative Pain

Keywords

Suzetrigine; NaV1.8 Inhibitor; Non-opioid analgesic; pelvic reconstructive surgery; transvaginal surgery; postoperative pain; opioid-sparing analgesia; multimodal pain management; pelvic organ prolapse; randomized clinical trial; stepped-wedge design; phase 4 trial

Outcome Measures

Primary Outcomes (1)

• Pain intensity (0-10 NRS) at 48 hours postoperatively

  Patient-reported postoperative pain intensity measured using the 0-10 Numerical Rating Scale (NRS).

  48 hours postoperatively

Secondary Outcomes (10)

• Pain Intensity at 1 Week

  1 week after surgery

• Time to Rescue Analgesia in PACU

  During stay in post-anesthesia care unit, measured in hours up to 23 hours

• Post-Discharge Opioid Use

  Postoperative days 0-7

• Post-Discharge Gabapentin Use

  Postoperative days 0-7

• Constipation

  Up to 1 week postoperatively

Study Arms (2)

Suzetrigine-Based Regimen

EXPERIMENTAL

Participants receive suzetrigine as part of a multimodal postoperative analgesic regimen. Suzetrigine is administered as a loading dose on the morning of surgery followed by twice-daily dosing for 7 days, in combination with scheduled acetaminophen and ibuprofen.

Drug: Suzetrigine; Drug: Scheduled Acetaminophen and Ibuprofen

Standard Opioid-Inclusive Analgesic Regimen

ACTIVE COMPARATOR

Participants receive standard postoperative pain management consisting of scheduled acetaminophen and ibuprofen, with opioid analgesics available as needed per routine clinical care.

Drug: Opioid Analgesics (Tramadol or Oxycodone); Drug: Scheduled Acetaminophen and Ibuprofen

Interventions

Suzetrigine DRUG

Loading dose: 100 mg orally on the morning of surgery Maintenance dose: 50 mg orally every 12 hours for 7 days Co-administered medications: Scheduled acetaminophen and ibuprofen Mechanism: Selective NaV1.8 sodium channel inhibitor acting on peripheral nociceptive neurons Purpose: Opioid-sparing postoperative analgesia

Suzetrigine-Based Regimen

Opioid Analgesics (Tramadol or Oxycodone) DRUG

Tramadol: 50 mg orally every 4-6 hours as needed OR Oxycodone: 5 mg orally every 4-6 hours as needed Co-administered medications: Scheduled acetaminophen and ibuprofen Purpose: Standard postoperative analgesia per institutional protocol

Standard Opioid-Inclusive Analgesic Regimen

Scheduled Acetaminophen and Ibuprofen DRUG

Participants in both study arms will receive scheduled acetaminophen and ibuprofen as part of standard multimodal postoperative analgesia. These medications are administered routinely following transvaginal pelvic reconstructive surgery to reduce baseline pain, minimize opioid requirements, and support enhanced recovery.

Standard Opioid-Inclusive Analgesic Regimen; Suzetrigine-Based Regimen

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years.
• Undergoing elective transvaginal pelvic reconstructive surgery at UCLA with planned same-day discharge or 23-hour observation.
• Able to provide written informed consent.

You may not qualify if:

• Chronic opioid use.
• Liver failure.
• End-stage renal disease (ESRD).
• Chronic pain syndromes, including:
• Fibromyalgia Interstitial cystitis Chronic pelvic pain
• Contraindication to acetaminophen or ibuprofen.
• Use of strong CYP3A4 inhibitors within 7 days prior to surgery or anticipated need during the treatment period.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles (UCLA)

Los Angeles, California, 90095, United States

Location

Related Publications (6)

• Dong S, Zhong Y, Chu L, Li H, Tong X, Wang J. Age-stratified analysis of long-term outcomes of transvaginal mesh repair for treatment of pelvic organ prolapse. Int J Gynaecol Obstet. 2016 Oct;135(1):112-6. doi: 10.1016/j.ijgo.2016.03.031. Epub 2016 Jun 20.

  PMID: 27392806 BACKGROUND

• Jelovsek JE, Maher C, Barber MD. Pelvic organ prolapse. Lancet. 2007 Mar 24;369(9566):1027-38. doi: 10.1016/S0140-6736(07)60462-0.

  PMID: 17382829 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.

  PMID: 31201808 BACKGROUND

• Keam SJ. Suzetrigine: First Approval. Drugs. 2025 Jun;85(6):845-851. doi: 10.1007/s40265-025-02178-w. Epub 2025 May 5.

  PMID: 40323340 BACKGROUND

• Ali MY, Antunes FTT, Huang S, Chen L, Zamponi GW. Pharmacological inhibition of NaV1.8 by suzetrigine reveals potent analgesic potential without tolerance development in mice. Mol Brain. 2025 Nov 13;18(1):86. doi: 10.1186/s13041-025-01253-3.

  PMID: 41233910 BACKGROUND

• Stewart RG, Osorno T, Fujita A, Jo S, Ferraiuolo A, Carlin K, Bean BP. Modulation of human dorsal root ganglion neuron firing by the Nav1.8 inhibitor suzetrigine. Proc Natl Acad Sci U S A. 2025 Jun 3;122(22):e2503570122. doi: 10.1073/pnas.2503570122. Epub 2025 May 27.

  PMID: 40424150 BACKGROUND

MeSH Terms

Conditions

Pelvic Organ Prolapse; Urinary Incontinence, Stress; Pain, Postoperative

Interventions

Analgesics, Opioid; Tramadol; Oxycodone; Ibuprofen

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• A Lenore Ackeman, MD, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

A Lenore Ackerman, MD, PhD

CONTACT

310-794-0206; aackerman@mednet.ucla.edu

Cindy Gu, MD

CONTACT

310-794-7700; cgu@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Treating surgeons will remain blinded to treatment allocation. Participants and study staff will not be blinded due to differences in medication appearance and administration.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Urology at UCLA, Director of Research, Division of Female Pelvic Medicine and Reconstructive Surgery at UCLA

Model Details: Stepped-wedge randomized design

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)