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Not Yet Recruiting NCT07654296

Assessing Suzetrigine for Pain Reduction Following Ureteroscopic Surgery

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

Sex: All
Ages: 21 Years – 80 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 100
Sponsor: Brigham and Women's Hospital

Location: Brigham and Women's Hospital Boston Massachusetts

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.

Eligibility Criteria

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).

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07654296). StuddyBuddy aggregates publicly available trial information.