Assessing Suzetrigine for Pain Reduction Following Ureteroscopic Surgery

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT07654296
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Multimodal Analgesia
  • Opioid Consumption, Postoperative
  • Ureteral Stent-Related Symptoms
  • Ureteral Stents
  • Ureteroscopy

Eligibility Criteria

Sex
ALL
Age
21 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • multimodal analgesia regimen without suzetrigine — DRUG
    multimodal analgesia regimen
  • Suzetrigine — DRUG
    suzetrigine with multimodal analgesia regimen

Study Details

Urologic surgery has advanced with new technologies to allow less invasive management of common afflictions such as kidney stones, these procedures are notoriously painful as the ureter must be dilated to accommodate any instruments, and a ureteral stent is often left following surgery to allow for adequate healing. Unfortunately, stents are poorly tolerated by a significant number of patients, with up to 100% complaining of bothersome pain and 10% of patients with unplanned healthcare visits. Further complicating kidney stone management is the frequency of concurrent chronic kidney disease (CKD) or acute kidney injury (AKI) that prohibits many patients from taking NSAIDs which limits pain management options. There is now a push to treat these patients with multimodal analgesia to provide better care and reduce opioid use. Suzetrigine is a new a first-in-class selective inhibitor of the NaV1.8 sodium channel that functions as a non-opioid analgesic developed to treat acute pain and neuropathic pain. This study assesses the addition of suzetrigine to standard-of-care multimodal analgesia. We hypothesize a demonstrated decrease in opioid use, decrease Emergency Room visits within 30 days, decrease the number of unplanned care encounters.

Key Dates

Start date
Aug 1, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

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

Arms

  • Active Comparator: multimodal analgesia pathway (standard, no suzetrigine)
    multimodal analgesia pathway without suzetrigine
  • Experimental: suzetrigine with multimodal analgesia pathway
    addition of suzetrigine to multimodal analgesia pathway

Primary Outcome Measure

Post-discharge opioid consumption (MME) [ Time Frame: 1-2 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's Faulkner HospitalBostonMassachusetts02130
Daniel A Wollin, MD, MS
[email protected]
617 732 6354
Brigham and Women's HospitalBostonMassachusetts02115
Daniel A Wollin, MD, MS
[email protected]
617 732 6354

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By research site
Brigham and Women's Faulkner Hospital· Boston, MABrigham and Women's Hospital· Boston, MA

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