Suzetrigine for Stent Pain
What You Need to Know Before You Apply
What is the purpose of 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.
Are You a Good Fit for This Trial?
This trial is for adults aged 21 to 80 having ureteroscopy (a kidney stone procedure) at BWFH, who can make their own medical decisions. People who regularly use opioids or have major substance abuse issues cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either standard multimodal analgesia or multimodal analgesia with suzetrigine following ureteroscopic surgery
Follow-up
Participants are monitored for opioid usage, unplanned care encounters, and patient-reported outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Suzetrigine
Trial Overview
The study compares standard pain management after ureteroscopy with and without a new non-opioid pain medicine called suzetrigine, to see if it reduces opioid use and unplanned healthcare visits.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
addition of suzetrigine to multimodal analgesia pathway
multimodal analgesia pathway without suzetrigine
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
Vertex Pharmaceuticals Incorporated
Industry Sponsor
Dr. David Altshuler
Vertex Pharmaceuticals Incorporated
Chief Medical Officer since 2020
MD, PhD
Dr. Reshma Kewalramani
Vertex Pharmaceuticals Incorporated
Chief Executive Officer since 2020
MD, trained in internal medicine and nephrology
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