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Precision Pain Management - A Randomized Clinical Trial Assessing the Efficacy of Suzetrigine on Postoperative Analgesia Among Surgical Patients at Higher Risk for Persistent Postoperative Opioid Use (POU)

2 juli 2026 bijgewerkt door: Rodney Gabriel, University of California, San Diego
The purpose of the study is to investigate the efficacy of suzetrigine for treatment of acute postoperative pain among surgical patients identified as high risk for persistent postoperative opioid use (POU). Using a validated artificial intelligence predictive model (termed SurgNet-POU) developed by the PI, electronic health record (EHR) data will be queried from all prospective surgical patients undergoing orthopedic surgery and inputted into the model to predict risk of POU (defined as requiring opioids ≥ 3 months after surgery). Those identified as high risk by the SurgNet-POU will be eligible candidates for this study. Suzetrigine (Vertex Pharmaceuticals) is an FDA-approved non-opioid oral analgesic that acts as a selective Nav1.8 sodium channel blocker. It has been shown to have efficacy in post-surgical pain and has compared favorably to placebo and similar to some opioids, without the risk of addiction or other adverse events related to opioids. Consented participants will be randomized to one of two arms: (1) standard care (termed standard care) defined as usual prescribing outpatient opioid analgesic protocols per surgical team; versus (2) standard care combined with 14-day regimen of suzetrigine. Those randomized to the suzetrigine arm will receive 100mg suzetrigine PO ~ 1-2 hours prior to surgery and take 50mg po twice a day for 14 days postoperatively. The primary outcome will be total opioid consumption over 14 days postoperatively. Secondary outcomes include average, highest and lowest pain scores at 7, 14, 30, and 90 days after surgery; and opioid consumption at 7, 30, and 90 days after surgery.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

The purpose of the study is to investigate the efficacy of suzetrigine for treatment of acute postoperative pain among surgical patients identified as high risk for persistent postoperative opioid use (POU). Using a validated artificial intelligence predictive model (termed SurgNet-POU) developed by the PI, electronic health record (EHR) data will be queried from all prospective surgical patients undergoing orthopedic surgery and inputted into the model to predict risk of POU (defined as requiring opioids ≥ 3 months after surgery). Those identified as high risk by the SurgNet-POU will be eligible candidates for this study. Suzetrigine (Vertex Pharmaceuticals) is an FDA-approved non-opioid oral analgesic that acts as a selective Nav1.8 sodium channel blocker. It has been shown to have efficacy in post-surgical pain and has compared favorably to placebo and similar to some opioids, without the risk of addiction or other adverse events related to opioids. Consented participants will be randomized to one of two arms: (1) standard care (termed standard care) defined as usual prescribing outpatient opioid analgesic protocols per surgical team; versus (2) standard care combined with 14-day regimen of suzetrigine. Those randomized to the suzetrigine arm will receive 100mg suzetrigine PO ~ 1-2 hours prior to surgery and take 50mg po twice a day for 14 days postoperatively. The primary outcome will be total opioid consumption over 14 days postoperatively. Secondary outcomes include average, highest and lowest pain scores at 7, 14, 30, and 90 days after surgery; and opioid consumption at 7, 30, and 90 days after surgery.

Our objective is to investigate the therapeutic benefits of suzetrigine for postoperative analgesia among patients identified as high risk for POU from our AI model, SurgNet-POU.

Primary Specific Aim. Demonstrate the potential efficacy of suzetrigine for postoperative analgesia in patients undergoing major surgery that are identified as high risk for POU. This will be performed as a pilot study and executed as a randomized clinical trial of up to 100 participants.

Hypothesis 1: Use of suzetrigine as part of a postoperative outpatient oral regimen will reduce 14-day postoperative opioid consumption in patients that are higher risk for POU.

Secondary Specific Aim: Among patients that are identified as high risk for POU after surgery, demonstrate the potential efficacy of suzetrigine in reducing pain and POU incidence after 3 months.

Hypothesis 1: Pain and opioid consumption will be reduced in the suzetrigine group compare to control at multiple post-procedure time points, including 1 week, 14 days, 1 month, and 3 months after.

There will be up to 100 participants recruited who are considered high risk for POU and undergoing major orthopedic surgery (hip arthroplasty, knee arthroplasty, shoulder arthroplasty, joint arthroscopy, foot/ankle surgery, upper extremity fracture surgery, spine surgery), breast surgery (mastectomy, breast reconstruction), gynecological surgery (hysterectomy, myomectomy), or abdominal surgery.

Studietype

Ingrijpend

Inschrijving (Geschat)

100

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • California
      • La Jolla, California, Verenigde Staten, 92037
        • Werving
        • University of California, San Diego
        • Hoofdonderzoeker:
          • Rodney A Gabriel, MD, MAS
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • Patients who are identified as high-risk for POU as calculated by our SurgNet-POU predictive deep learning model. The probability threshold will be set at ~> 0.25. Potential participants will be screened prior to surgery by incorporating their electronic health record data in to the model.
  • Patients undergoing major orthopedic surgery (hip arthroplasty, knee arthroplasty, shoulder arthroplasty, joint arthroscopy, foot/ankle surgery, upper extremity fracture surgery, spine surgery), breast surgery (mastectomy, breast reconstruction), gynecological surgery (hysterectomy, myomectomy), or abdominal surgery.
  • Adult patients of at least 18 years of age
  • Has the capacity to consent

Exclusion Criteria:

  • Pregnancy
  • Incarceration
  • Patients with a previous history of opioid use disorder.
  • Patients on fentanyl transdermal patch, methadone, and/or buprenorphine.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Suzetrigine + Standard Care (standard outpatient analgesic prescriptions per surgical team)
Suzetrigine is a selective sodium channel blocker, specifically targeting the Nav1.8 sodium channel found in peripheral pain-sensing nerves. Suzetrigine has been FDA approved for acute pain management for moderate-to-severe acute pain (e.g., post-surgical pain) and represents the first new class of pain medication in decades. Compared to opioids, there is no risk of respiratory depression, no associated euphoria (thus lower addiction risk), and does not act on the opioid receptors. Compared to NSAIDs, it has no kidney or GI bleeding risk or effects on the platelets. For participants randomized to this arm, they will receive 100mg po once preoperatively (approximately 1 - 2 hours prior to surgery) in the preoperative holding area. They will then receive 14 days 50mg po twice a day (first dose to start the evening of postoperative day 0. In addition, the participants will receive standard outpatient analgesic prescribing per their surgical provider.
Geneesmiddel: Suzetrigine
In addition to standard postoperative analgesia care (per surgeon), the participant in the intervention arm will receive a 14-day dosing regimen for suzetrigine.
Andere namen:
  • Journavx
Actieve vergelijker: Standard Care Alone
Participants in this group will receive standard outpatient analgesic prescribing (combination of opioids, NSAIDs, acetaminophen) per their surgical provider. No placebo pill will be administered.
Geneesmiddel: Standard Care (in control arm)
participants will receive the standard postoperative analgesia care provided by their surgeon.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Total Opioid Consumption Over 14 Days Postoperatively
Tijdsspanne: From enrollment to 14 days postoperatively
Primary endpoint - total opioid consumption over the first 14 postoperative days (standardized to oral morphine equivalents in milligrams)
From enrollment to 14 days postoperatively

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of Persistent Opioid Use (POU)
Tijdsspanne: From enrollment to 3 months after surgery.
Incidence of POU, defined as any opioid consumption required at ≥ 3 months after surgery.
From enrollment to 3 months after surgery.
Opioid Consumption Over Last 7 Days
Tijdsspanne: From enrollment to 3 months after surgery.
Opioid consumption over last 7 days at 1 week, 1 month, and 3 months after surgery (standardized to oral oxycodone equivalents in milligrams).
From enrollment to 3 months after surgery.
Average, Worst, and Best Pain Over Last 7 Days
Tijdsspanne: From enrollment to 3 months after surgery.
Average, worst, and best pain, measured as the 11-point Numeric Rating Scale for pain (0-10) over the last 7 days at 1 week, 14 days, 1 month, and 3 months after surgery. The lower the score on the scale corresponds to less pain and the higher the score corresponds the more pain (worse outcome).
From enrollment to 3 months after surgery.
opioid-related side effects
Tijdsspanne: 1 week, 14 days, 1 month, and 3 months after surgery
incidence of any opioid-related side effects over last 7 days at 1 week, 14 days, 1 month, and 3 months after surgery. These opioid-related side effects will include nausea, vomiting, sedation, and constipation.
1 week, 14 days, 1 month, and 3 months after surgery

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of California, San Diego

Medewerkers

Wellcome Leap Inc.

Onderzoekers

  • Hoofdonderzoeker: Rodney A Gabriel, MD, MAS, University of California, San Diego

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

2 juli 2026

Primaire voltooiing (Geschat)

1 juni 2027

Studie voltooiing (Geschat)

1 juni 2027

Studieregistratiedata

Eerst ingediend

22 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

22 juni 2026

Eerst geplaatst (Werkelijk)

26 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

2 juli 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 814697

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Beschrijving IPD-plan

due to HIPAA regulations

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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