Recruiting
Phase 3

Suzetrigine with Multimodal Analgesia

Sponsor:

Brigham and Women's Hospital

Code:

NCT07654296

Conditions

Opioid Consumption, Postoperative

Multimodal Analgesia

Ureteroscopy

Ureteral Stents

Ureteral Stent-Related Symptoms

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

multimodal analgesia regimen without suzetrigine

Suzetrigine

Study Details

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

Study ID

NCT07654296

Start date

Oct 20, 2026

Status verified date

Nov, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

multimodal analgesia regimen without suzetrigine

multimodal analgesia regimen

Suzetrigine

suzetrigine with multimodal analgesia regimen

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Daniel A Wollin, MD, MS

617 732 6354dwollin@mgb.org

Christopher Magnani, MD, MS, MPhil

CMAGNANI@BWH.HARVARD.EDU

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Daniel A Wollin, MD, MS

617 732 6354dwollin@mgb.org

Brigham and Women's Faulkner Hospital

Recruiting

Boston, Massachusetts, United States, 02130

Contacts

Daniel A Wollin, MD, MS

617 732 6354dwollin@mgb.org

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Nov 13, 2026

Last verified

Nov, 2026

Keywords

  • Multimodal Analgesia
  • Postoperative Opioid Consumption
  • ureteroscopy
  • ureteral stents

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-14. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-11-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.