Assessing Suzetrigine for Pain Reduction Following Ureteroscopic Surgery

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age21-80
SponsorBrigham and Women's Hospital

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Regular opioid use prior to surgery or significant substance abuse concerns.

Inability of patient to provide their own consent (i.e. lack capacity).

Trial design

Design model

Parallel

Treatments tested in this trial

  • multimodal analgesia regimen without suzetrigine

    Drug

    multimodal analgesia regimen

  • Suzetrigine

    Drug

    suzetrigine with multimodal analgesia regimen

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: multimodal analgesia pathway (standard, no suzetrigine)Active comparator 1 intervention
Group B: suzetrigine with multimodal analgesia pathwayExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Post-discharge opioid consumption (MME)

assessed at post-operative visit

Time frame
1-2 weeks

Secondary outcomes

1

Post-discharge opioid consumption (MME)

assessed at 30 days after surgery

Time frame
30 days
2

Rate of unplanned care encounters

Emergency Room visits

Time frame
30 days
3

patient reported outcomes: pain score

measured on a 0 to 10 analog scale on post-operative survey

Time frame
2 weeks
4

patient reported outcomes: pain score

measured on a 0 to 10 analog scale on post-operative survey

Time frame
30 days

Other outcomes

Sponsors and contacts

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Brigham and Women's Hospital

Lead sponsor

Vertex Pharmaceuticals Incorporated

Collaborator

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