About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Regular opioid use prior to surgery or significant substance abuse concerns.
Inability of patient to provide their own consent (i.e. lack capacity).
Trial design
Parallel
Treatments tested in this trial
multimodal analgesia regimen without suzetrigine
Drugmultimodal analgesia regimen
Suzetrigine
Drugsuzetrigine with multimodal analgesia regimen
Treatment groups
Trial outcomes
Primary outcomes
Post-discharge opioid consumption (MME)
assessed at post-operative visit
Secondary outcomes
Post-discharge opioid consumption (MME)
assessed at 30 days after surgery
Rate of unplanned care encounters
Emergency Room visits
patient reported outcomes: pain score
measured on a 0 to 10 analog scale on post-operative survey
patient reported outcomes: pain score
measured on a 0 to 10 analog scale on post-operative survey
Sponsors and contacts
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Brigham and Women's Hospital
Lead sponsor
Vertex Pharmaceuticals Incorporated
Collaborator
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