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Assessing Suzetrigine for Pain Reduction Following Ureteroscopic Surgery

NCT07654296 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-06-17

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

multimodal analgesia regimen without suzetrigine

multimodal analgesia regimen

DRUG

Suzetrigine

suzetrigine with multimodal analgesia regimen

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2026-12-31
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07654296 on ClinicalTrials.gov