Assessing Suzetrigine for Pain Reduction Following Ureteroscopic Surgery

NCT07654296 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: 2026P000126
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Multimodal Analgesia; Postoperative Opioid Consumption; ureteroscopy; ureteral stents

Outcome Measures

Primary Outcomes (1)

• Post-discharge opioid consumption (MME)

  assessed at post-operative visit

  1-2 weeks

Secondary Outcomes (18)

• Post-discharge opioid consumption (MME)

  30 days

• Rate of unplanned care encounters

  30 days

• patient reported outcomes: pain score

  2 weeks

• patient reported outcomes: pain score

  30 days

• patient reported outcomes: PROMIS composite score

  2 weeks

Study Arms (2)

multimodal analgesia pathway (standard, no suzetrigine)

ACTIVE COMPARATOR

multimodal analgesia pathway without suzetrigine

Drug: multimodal analgesia regimen without suzetrigine

suzetrigine with multimodal analgesia pathway

EXPERIMENTAL

addition of suzetrigine to multimodal analgesia pathway

Drug: Suzetrigine

Interventions

multimodal analgesia regimen without suzetrigine DRUG

multimodal analgesia regimen

multimodal analgesia pathway (standard, no suzetrigine)

Suzetrigine DRUG

suzetrigine with multimodal analgesia regimen

suzetrigine with multimodal analgesia pathway

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Regular opioid use prior to surgery or significant substance abuse concerns.
• Inability of patient to provide their own consent (i.e. lack capacity).

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Vertex Pharmaceuticals Incorporated: collaborator

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Brigham and Women's Faulkner Hospital

Boston, Massachusetts, 02130, United States

Location

Central Study Contacts

Daniel A Wollin, MD, MS

CONTACT

617 732 6354; dwollin@mgb.org

Christopher Magnani, MD, MS, MPhil

CONTACT

CMAGNANI@BWH.HARVARD.EDU

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Surgeon

Model Details: Pre/post intervention model where the two parallel arm assignments occur either before or after the addition of suzetrigine to the standard-of-care multimodal analgesia regimen.

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 17, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)