Opioid Consumption, PostoperativePhase 3NCT07654296
Assessing Suzetrigine for Pain Reduction Following Ureteroscopic Surgery
A Phase 3 study testing multimodal analgesia regimen without suzetrigine and Suzetrigine in people with Opioid Consumption, Postoperative and Multimodal Analgesia, run by Brigham and Women's Hospital at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Opioid Consumption, Postoperative, Multimodal Analgesia, Ureteroscopy
- What is being tested?
- multimodal analgesia regimen without suzetrigine and Suzetrigine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2026to 31 Mar 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Regular opioid use prior to surgery or significant substance abuse concerns.
- Inability of patient to provide their own consent (i.e. lack capacity).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Christopher Magnani, MD, MS, MPhil contact
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Daniel A Wollin, MD, MS, 617 732 6354, dwollin@mgb.org
Brigham and Women's Faulkner Hospital
Boston, Massachusetts, 02130
Daniel A Wollin, MD, MS, 617 732 6354, dwollin@mgb.org
About this study
Official title: Multimodal Analgesia Pathway Assessing Role of Suzetrigine for the Reduction of Opioid Use Following Ureteroscopic Surgery
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.
Read the 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).
- Conditions
- Opioid Consumption, Postoperative, Multimodal Analgesia, Ureteroscopy, Ureteral Stents, Ureteral Stent-Related Symptoms
- Being tested
- multimodal analgesia regimen without suzetrigine, Suzetrigine
- Keywords
- Multimodal Analgesia, Postoperative Opioid Consumption, ureteroscopy, ureteral stents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multimodal analgesia regimen without suzetrigineDrug
multimodal analgesia regimen
SuzetrigineDrug
suzetrigine with multimodal analgesia regimen
| Study group | Role | What they receive |
|---|---|---|
| multimodal analgesia pathway (standard, no suzetrigine) | Active comparator | multimodal analgesia pathway without suzetrigine Receives: Drug: multimodal analgesia regimen without suzetrigine |
| suzetrigine with multimodal analgesia pathway | Experimental | addition of suzetrigine to multimodal analgesia pathway Receives: Drug: Suzetrigine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-discharge opioid consumption (MME)
assessed at post-operative visit
Measured: 1-2 weeks
Secondary outcomes (18)
Post-discharge opioid consumption (MME)
assessed at 30 days after surgery
Measured: 30 days
Rate of unplanned care encounters
Emergency Room visits
Measured: 30 days
patient reported outcomes: pain score
measured on a 0 to 10 analog scale on post-operative survey
Measured: 2 weeks
patient reported outcomes: pain score
measured on a 0 to 10 analog scale on post-operative survey
Measured: 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:
- How much did pain interfere with your day-to-day activities?
- How much did pain interfere with work around the home?
- How much did pain interfere with your ability to participate in social activities?
- How much did pain interfere with your household chores?
- How much did pain interfere with things you usually do for fun?
- How much did pain interfere with your enjoyment of social activities?
Measured: 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:
- How much did pain interfere with your day-to-day activities?
- How much did pain interfere with work around the home?
- How much did pain interfere with your ability to participate in social activities?
- How much did pain interfere with your household chores?
- How much did pain interfere with things you usually do for fun?
- How much did pain interfere with your enjoyment of social activities?
Measured: 30 days
patient reported outcomes (PROMIS) pain interfere with your day-to-day activities
rated from 0 to 4
Measured: 2 weeks
patient reported outcomes (PROMIS) pain interfere with your day-to-day activities
rated from 0 to 4
Measured: 30 days
patient reported outcomes (PROMIS) pain interfere with work around the home
rated from 0 to 4
Measured: 2 weeks
patient reported outcomes (PROMIS) pain interfere with work around the home
rated from 0 to 4
Measured: 30 days
patient reported outcomes (PROMIS) pain interfere with your ability to participate in social activities
rated from 0 to 4
Measured: 2 weeks
patient reported outcomes (PROMIS) pain interfere with your ability to participate in social activities
rated from 0 to 4
Measured: 30 days
patient reported outcomes (PROMIS) pain interfere with your household chores
rated from 0 to 4
Measured: 2 weeks
patient reported outcomes (PROMIS) pain interfere with your household chores
rated from 0 to 4
Measured: 30 days
patient reported outcomes (PROMIS) pain interfere with things you usually do for fun
rated from 0 to 4
Measured: 2 weeks
patient reported outcomes (PROMIS) pain interfere with things you usually do for fun
rated from 0 to 4
Measured: 30 days
patient reported outcomes (PROMIS) pain interfere with your enjoyment of social activities
rated from 0 to 4
Measured: 2 weeks
patient reported outcomes (PROMIS) pain interfere with your enjoyment of social activities
rated from 0 to 4
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Consumption, PostoperativeStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Vertex Pharmaceuticals Incorporated
- Responsible party
- Principal investigator, Daniel A. Wollin, MD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07654296
- Sponsor's protocol ID
- 2026P000126
- Status last verified
- Sep 2026
- First submitted
- 3 Jun 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Analgesia Pathway Assessing Role of Suzetrigine for the Reduction of Opioid Use Following Ureteroscopic Surgery
- ClinicalTrials.gov ID
- NCT07654296
- Acronym / sponsor ID
- 2026P000126
- Conditions
- Opioid Consumption, Postoperative, Multimodal Analgesia, Ureteroscopy, Ureteral Stents, Ureteral Stent-Related Symptoms
- Keywords
- Multimodal Analgesia, Postoperative Opioid Consumption, ureteroscopy, ureteral stents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Vertex Pharmaceuticals Incorporated
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| multimodal analgesia pathway (standard, no suzetrigine) | Active comparator | Drug: multimodal analgesia regimen without suzetriginemultimodal analgesia pathway without suzetrigine |
| suzetrigine with multimodal analgesia pathway | Experimental | Drug: Suzetrigineaddition of suzetrigine to multimodal analgesia pathway |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- Regular opioid use prior to surgery or significant substance abuse concerns.
- Inability of patient to provide their own consent (i.e. lack capacity).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multimodal analgesia regimen without suzetriginemultimodal analgesia regimen | Drug | multimodal analgesia pathway (standard, no suzetrigine) |
| Suzetriginesuzetrigine with multimodal analgesia regimen | Drug | suzetrigine with multimodal analgesia pathway |
Primary outcome
Post-discharge opioid consumption (MME)
Time frame: 1-2 weeks
assessed at post-operative visit
18 secondary outcomes
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
patient reported outcomes (PROMIS) pain interfere with your household chores
Time frame: 2 weeks
patient reported outcomes (PROMIS) pain interfere with your household chores
Time frame: 30 days
patient reported outcomes (PROMIS) pain interfere with things you usually do for fun
Time frame: 2 weeks
patient reported outcomes (PROMIS) pain interfere with things you usually do for fun
Time frame: 30 days
patient reported outcomes (PROMIS) pain interfere with your enjoyment of social activities
Time frame: 2 weeks
patient reported outcomes (PROMIS) pain interfere with your enjoyment of social activities
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher Magnani, MD, MS, MPhil contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing multimodal analgesia regimen without suzetrigine and Suzetrigine in people with Opioid Consumption, Postoperative and Multimodal Analgesia, run by Brigham and Women's Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel A Wollin, MD, MS (617 732 6354, dwollin@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-discharge opioid consumption (MME) (time frame: 1-2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.