Assessing Suzetrigine for Pain Reduction Following Ureteroscopic Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: multimodal analgesia regimen without suzetrigine, Suzetrigine.
- Who it may be relevant to
- Registry conditions: Opioid Consumption, Postoperative, Multimodal Analgesia, Ureteroscopy, Ureteral Stents. Basic parameters: 21 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Multimodal Analgesia Pathway Assessing Role of Suzetrigine for the Reduction of Opioid Use Following Ureteroscopic Surgery
Overview
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.
Detailed description
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. This prospective open-label interventional single-center study will compare 30-day postoperative patient reported outcomes and pain medication use between a pre-implementation cohort of patients managed with standard-of-care multimodal analgesia after ureteroscopy with a post-implementation cohort of patient with this regimen and addition of suzetrigine. The primary outcome will be opioid usage after discharge with standard of care multimodal analgesia (historical control) vs opioid usage after discharge with suzetrigine included with the standard of care
multimodal analgesia regimen (intervention). Secondary outcomes will include unplanned care encounters within 30 days (Emergency Room, unplanned clinic visits) and surveyed patient reported outcomes measured on a post-operative survey including PROMIS (Patient-Reported Outcomes Measurement Information System) questions as well as an end of study administration of WISQOL (The Wisconsin Stone Quality of Life Questionnaire). The study will be conducted within a single academic institution including the primary hospital (Brigham and Women's Hospital) and satellite sites (Brigham and Women's Faulkner Hospital).
Interventions
- Drug multimodal analgesia regimen without suzetrigine
multimodal analgesia regimen - Drug Suzetrigine
suzetrigine with multimodal analgesia regimen
Primary outcome measures
- Post-discharge opioid consumption (MME) [Time frame: 1-2 weeks]
Secondary outcome measures (12)
- Post-discharge opioid consumption (MME) [Time frame: 30 days]
- Rate of unplanned care encounters [Time frame: 30 days]
- patient reported outcomes: pain score [Time frame: 2 weeks]
- patient reported outcomes: pain score [Time frame: 30 days]
- patient reported outcomes: PROMIS composite score [Time frame: 2 weeks]
- patient reported outcomes: PROMIS composite score [Time frame: 30 days]
- patient reported outcomes (PROMIS) pain interfere with your day-to-day activities [Time frame: 2 weeks]
- patient reported outcomes (PROMIS) pain interfere with your day-to-day activities [Time frame: 30 days]
- patient reported outcomes (PROMIS) pain interfere with work around the home [Time frame: 2 weeks]
- patient reported outcomes (PROMIS) pain interfere with work around the home [Time frame: 30 days]
- patient reported outcomes (PROMIS) pain interfere with your ability to participate in social activities [Time frame: 2 weeks]
- patient reported outcomes (PROMIS) pain interfere with your ability to participate in social activities [Time frame: 30 days]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Brigham and Women's Hospital — Boston
- Brigham and Women's Faulkner Hospital — Boston
Identifiers
NCT: NCT07654296 · 2026P000126