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)

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT07672015
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Opioid Consumption, Postoperative

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Suzetrigine — DRUG
    In addition to standard postoperative analgesia care (per surgeon), the participant in the intervention arm will receive a 14-day dosing regimen for suzetrigine.
  • Standard Care (in control arm) — DRUG
    participants will receive the standard postoperative analgesia care provided by their surgeon.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Total Opioid Consumption Over 14 Days Postoperatively [ Time Frame: From enrollment to 14 days postoperatively ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San DiegoLa JollaCalifornia92037
Rodney A Gabriel
[email protected]
858-663-7747
Rodney A Gabriel, MD, MAS (PRINCIPAL_INVESTIGATOR)

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By research site
University of California, San Diego· La Jolla, CA

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