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| Name | Class |
|---|---|
| Vertex Pharmaceuticals Incorporated | INDUSTRY |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| multimodal analgesia pathway (standard, no suzetrigine) | Active Comparator | multimodal analgesia pathway without suzetrigine |
|
| suzetrigine with multimodal analgesia pathway | Experimental | addition of suzetrigine to multimodal analgesia pathway |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multimodal analgesia regimen without suzetrigine | Drug | multimodal analgesia regimen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-discharge opioid consumption (MME) | assessed at post-operative visit | 1-2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Post-discharge opioid consumption (MME) | assessed at 30 days after surgery | 30 days |
| Rate of unplanned care encounters | Emergency Room visits |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel A Wollin, MD, MS | Contact | 617 732 6354 | dwollin@mgb.org | |
| Christopher Magnani, MD, MS, MPhil | Contact | CMAGNANI@BWH.HARVARD.EDU |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
This trial is being performed at within a single institution (Mass General Brigham) at two of it's constituent sites (BWH and BWFH), as part of IRB approval of the study decision was for privacy policy that only aggregated data would be intended to be shared outside the institutions system and any IPD would be solely stored on HIPAA compliant servers at the facility. De-identified or aggregated data would be permitted to be shared so long as subjects could not be identified.
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Pre/post intervention model where the two parallel arm assignments occur either before or after the addition of suzetrigine to the standard-of-care multimodal analgesia regimen.
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| Suzetrigine | Drug | suzetrigine with multimodal analgesia regimen |
|
| 30 days |
| patient reported outcomes: pain score | measured on a 0 to 10 analog scale on post-operative survey | 2 weeks |
| patient reported outcomes: pain score | measured on a 0 to 10 analog scale on post-operative survey | 30 days |
| patient reported outcomes: PROMIS composite score | total score where each of the following is rated from 0 to 4 then aggregated into a total value:
| 2 weeks |
| patient reported outcomes: PROMIS composite score | total score where each of the following is rated from 0 to 4 then aggregated into a total value:
| 30 days |
| patient reported outcomes (PROMIS) pain interfere with your day-to-day activities | rated from 0 to 4 | 2 weeks |
| patient reported outcomes (PROMIS) pain interfere with your day-to-day activities | rated from 0 to 4 | 30 days |
| patient reported outcomes (PROMIS) pain interfere with work around the home | rated from 0 to 4 | 2 weeks |
| patient reported outcomes (PROMIS) pain interfere with work around the home | rated from 0 to 4 | 30 days |
| patient reported outcomes (PROMIS) pain interfere with your ability to participate in social activities | rated from 0 to 4 | 2 weeks |
| patient reported outcomes (PROMIS) pain interfere with your ability to participate in social activities | rated from 0 to 4 | 30 days |
| patient reported outcomes (PROMIS) pain interfere with your household chores | rated from 0 to 4 | 2 weeks |
| patient reported outcomes (PROMIS) pain interfere with your household chores | rated from 0 to 4 | 30 days |
| patient reported outcomes (PROMIS) pain interfere with things you usually do for fun | rated from 0 to 4 | 2 weeks |
| patient reported outcomes (PROMIS) pain interfere with things you usually do for fun | rated from 0 to 4 | 30 days |
| patient reported outcomes (PROMIS) pain interfere with your enjoyment of social activities | rated from 0 to 4 | 2 weeks |
| patient reported outcomes (PROMIS) pain interfere with your enjoyment of social activities | rated from 0 to 4 | 30 days |
| Brigham and Women's Faulkner Hospital | Boston | Massachusetts | 02130 | United States |
|