Assessing Suzetrigine for Pain Reduction Following Ureteroscopic Surgery

Recruitment Status
NOT YET RECRUITING
(See Contacts and Locations)Verified May 2026 by Brigham and Women's Hospital
Sponsor
Brigham and Women's Hospital
Information Provided by (Responsible Party)
Daniel A. Wollin, MD
Clinicaltrials.gov Identifier
NCT07654296
Other Study ID Numbers:
2026P000126
First Submitted
June 2, 2026
First Posted
June 16, 2026
Last Update Posted
June 16, 2026
Last Verified
May 2026

ClinicalTrials.gov processed this data on June 2026Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

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. This prospective open-label interventional single-center study will compare 30-day postoperative patient reported outcomes and pain medication use between a pre-implementation cohort of patients managed with standard-of-care multimodal analgesia after ureteroscopy with a post-implementation cohort of patient with this regimen and addition of suzetrigine. The primary outcome will be opioid usage after discharge with standard of care multimodal analgesia (historical control) vs opioid usage after discharge with suzetrigine included with the standard of care

multimodal analgesia regimen (intervention). Secondary outcomes will include unplanned care encounters within 30 days (Emergency Room, unplanned clinic visits) and surveyed patient reported outcomes measured on a post-operative survey including PROMIS (Patient-Reported Outcomes Measurement Information System) questions as well as an end of study administration of WISQOL (The Wisconsin Stone Quality of Life Questionnaire). The study will be conducted within a single academic institution including the primary hospital (Brigham and Women's Hospital) and satellite sites (Brigham and Women's Faulkner Hospital).

Condition or DiseaseIntervention/Treatment
Opioid Consumption, PostoperativeMultimodal AnalgesiaUreteroscopyUreteral StentsUreteral Stent-Related Symptoms
Drug: multimodal analgesia regimen without suzetrigineDrug: Suzetrigine

Study Design

Study TypeInterventional
Actual Enrollment100 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleMultimodal Analgesia Pathway Assessing Role of Suzetrigine for the Reduction of Opioid Use Following Ureteroscopic Surgery
Study Start DateJuly 31, 2026
Actual Primary Completion Date4mos 3w from now
Actual Study Completion Date7mos 3w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
multimodal analgesia pathway (standard, no suzetrigine)
multimodal analgesia pathway without suzetrigine
Drug: multimodal analgesia regimen without suzetrigine
multimodal analgesia regimen
suzetrigine with multimodal analgesia pathway
addition of suzetrigine to multimodal analgesia pathway
Drug: Suzetrigine
suzetrigine with multimodal analgesia regimen

Outcome Measures

Primary Outcome Measures
  1. Post-discharge opioid consumption (MME)
    assessed at post-operative visit
Secondary Outcome Measures
  1. Post-discharge opioid consumption (MME)
    assessed at 30 days after surgery
  2. Rate of unplanned care encounters
    Emergency Room visits
  3. patient reported outcomes: pain score
    measured on a 0 to 10 analog scale on post-operative survey
  4. patient reported outcomes: pain score
    measured on a 0 to 10 analog scale on post-operative survey
  5. patient reported outcomes: PROMIS composite score
    total score where each of the following is rated from 0 to 4 then aggregated into a total value: 1. How much did pain interfere with your day-to-day activities? 2. How much did pain interfere with work around the home? 3. How much did pain interfere with your ability to participate in social activities? 4. How much did pain interfere with your household chores? 5. How much did pain interfere with things you usually do for fun? 6. How much did pain interfere with your enjoyment of social activities?
  6. patient reported outcomes: PROMIS composite score
    total score where each of the following is rated from 0 to 4 then aggregated into a total value: 1. How much did pain interfere with your day-to-day activities? 2. How much did pain interfere with work around the home? 3. How much did pain interfere with your ability to participate in social activities? 4. How much did pain interfere with your household chores? 5. How much did pain interfere with things you usually do for fun? 6. How much did pain interfere with your enjoyment of social activities?
  7. patient reported outcomes (PROMIS) pain interfere with your day-to-day activities
    rated from 0 to 4
  8. patient reported outcomes (PROMIS) pain interfere with your day-to-day activities
    rated from 0 to 4
  9. patient reported outcomes (PROMIS) pain interfere with work around the home
    rated from 0 to 4
  10. patient reported outcomes (PROMIS) pain interfere with work around the home
    rated from 0 to 4
  11. patient reported outcomes (PROMIS) pain interfere with your ability to participate in social activities
    rated from 0 to 4
  12. patient reported outcomes (PROMIS) pain interfere with your ability to participate in social activities
    rated from 0 to 4
  13. patient reported outcomes (PROMIS) pain interfere with your household chores
    rated from 0 to 4
  14. patient reported outcomes (PROMIS) pain interfere with your household chores
    rated from 0 to 4
  15. patient reported outcomes (PROMIS) pain interfere with things you usually do for fun
    rated from 0 to 4
  16. patient reported outcomes (PROMIS) pain interfere with things you usually do for fun
    rated from 0 to 4
  17. patient reported outcomes (PROMIS) pain interfere with your enjoyment of social activities
    rated from 0 to 4
  18. patient reported outcomes (PROMIS) pain interfere with your enjoyment of social activities
    rated from 0 to 4

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Patients undergoing ureteroscopy between ages 21 to 80 at BWFH (Brigham \& Women's Faulkner Hospital) by one of the department's high volume endoscopic surgeons. Patient who are or not pre-stented prior to surgery will be included (these will be assessed via stratification within a secondary analysis).
Patients able to consent for their own medical care (i.e. consent able to be obtained directly from patient and does not require a healthcare proxy or guardian)
Exclusion Criteria
Regular opioid use prior to surgery or significant substance abuse concerns.
Inability of patient to provide their own consent (i.e. lack capacity).

Contacts and Locations

Sponsors and CollaboratorsBrigham and Women's Hospital
Locations
Brigham and Women's Hospital | Boston Massachusetts, United States, 02115Brigham and Women's Faulkner Hospital | Boston Massachusetts, United States, 02130