Multimodal Analgesia, Opioid Consumption, Postoperative, Ureteral Stent-Related Symptoms, Ureteral Stents, Ureteroscopy
Conditions
Keywords
Multimodal Analgesia, Postoperative Opioid Consumption, ureteroscopy, ureteral stents
Brief 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.
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
DRUGmultimodal analgesia regimen without suzetrigine
multimodal analgesia regimen
DRUGSuzetrigine
suzetrigine with multimodal analgesia regimen
Sponsors
Brigham and Women's Hospital
Vertex Pharmaceuticals Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-discharge opioid consumption (MME) | 1-2 weeks | assessed at post-operative visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-discharge opioid consumption (MME) | 30 days | assessed at 30 days after surgery |
| Rate of unplanned care encounters | 30 days | Emergency Room visits |
| patient reported outcomes: pain score | 2 weeks | measured on a 0 to 10 analog scale on post-operative survey |
| patient reported outcomes: PROMIS composite score | 2 weeks | total score where each of the following is rated from 0 to 4 then aggregated into a total value: 1. How much did pain interfere with your day-to-day activities? 2. How much did pain interfere with work around the home? 3. How much did pain interfere with your ability to participate in social activities? 4. How much did pain interfere with your household chores? 5. How much did pain interfere with things you usually do for fun? 6. How much did pain interfere with your enjoyment of social activities? |
| patient reported outcomes (PROMIS) pain interfere with your day-to-day activities | 2 weeks | rated from 0 to 4 |
| patient reported outcomes (PROMIS) pain interfere with work around the home | 2 weeks | rated from 0 to 4 |
| patient reported outcomes (PROMIS) pain interfere with your ability to participate in social activities | 2 weeks | rated from 0 to 4 |
| patient reported outcomes (PROMIS) pain interfere with your household chores | 2 weeks | rated from 0 to 4 |
| patient reported outcomes (PROMIS) pain interfere with things you usually do for fun | 2 weeks | rated from 0 to 4 |
| patient reported outcomes (PROMIS) pain interfere with your enjoyment of social activities | 2 weeks | rated from 0 to 4 |
Countries
United States
Contacts
CONTACTDaniel A Wollin, MD, MS
CONTACTChristopher Magnani, MD, MS, MPhil
Outcome results
None listed