Suzetrigine in TKA

Browse trials for

• Agnosia 1,190
• Pain 2,219

Agnosia

1,190 studies on the registry are indexed under Agnosia; 508 are open to participants now.

This study's planned enrollment of 148 is above the median of 78 across 1,024 interventional studies indexed under Agnosia.

Lead sponsor

Hospital for Special Surgery, New York is the lead sponsor of 218 studies on the registry; 40 are open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 20 (74%) have results posted.

Study arms

• Placebo comparator
  Placebo arm

  Other: Placebo

• Experimental
  Suzetrigine

  Drug: Suzetrigine

Interventions

• OtherPlacebo

  This will be a placebo drug.

• DrugSuzetrigine

  Suzetrigine is a new novel peripherally acting non-opioid pain medication recently approved by the FDA that exerts its analgesic effects by binding to the peripherally located Nav1.8 Sodium channel receptors present on peripheral nerves.

Primary outcomes

1. Cumulative opioid consumption within the first 48 hours after TKA starting from post-anesthesia care unit entry (t=0), in oral morphine equivalents (OME)

   Time frame: From entry into the post-anesthesia care unit (PACU) to 48 hours after THA surgery

Secondary outcomes

1. NRS (current at rest, with ambulation, worst & least in last 24 hours) Post-Operative Day (POD) 1-14

   Time frame: From admission to the Post Anesthesia Care Unit (PACU) through 14 days postoperatively (Post-Op Day 14)

2. Numeric Rating Scale - post-anesthesia care unit: average, least, worst

   Numeric Rating Scale in Post-Anesthesia Care Unit (PACU) ranging from average to least to worst. Post operative pain using Numeric Rating Scale(current at rest, with ambulation, worst \& least in last 24 hours). The Numeric Rating Scale is a simple, widely used tool for measuring pain intensity. It consists of a 0-10 point scale. This will be measured after surgery in the PACU.

   Time frame: From arrival in PACU until discharge criteria are met (expected duration up to 2 hours postoperatively).

3. Numeric Rating Scale @Post-Operative Day14, @week 6, @week 12 - average pain, worst & least: last 7 days; current

   Numeric Rating Scale measured at 14 days following surgery, then at 6 weeks following surgery and then 12 weeks following surgery. Measurements will range from average pain to worst pain to least amount of pain over the last 7 days and current pain.

   Time frame: From 14 days following surgery, 6 weeks from surgery and 12 weeks from surgery.

4. Cumulative Opioid consumption (Oral morphine equivalents = OME): post-anesthesia care unit, 0-24hours, 0 to 168 hours (7 days postoperatively) 0-Post-Operative Day14

   Cumulative Opioid consumption (Oral morphine equivalents = OME): Post anesthesia care unit (PACU) at 0 and 24hours, 168 hours, and 14 days (i.e. 7 days postoperatively). The primary outcome is cumulative consumption in oral morphine equivalents starting from entry into the post-anesthesia care unit (PACU). This measure will be taken from EPIC via the MAR and documented in the study "MUD"; post-discharge, patient to report date/time of opioid use # of pills, dose in diary and documented in study "MUD". Measurements will be taken in PACU, 0-24hrs, 0-48 hrs and 0-168hrs following surgery.

   Time frame: from first time in PACU to 24hours after, then 168hours after, and to 14 days after

5. Opioid-free patients through Post-Operative Day2 (0-48hrs), Post-Operative Day7 (0-168hrs), Post-Operative Day14 (0-day 14)

   Patients that no longer require opioid medications at Postoperative day 2 (48hrs), 7 (168hrs) and 14

   Time frame: From start of trial to post operative day 2, 7 and 14

6. Currently taking opioids & Opioid refills (Y/N, assessed @Post-Operative Day14, @6 week, @12 week)

   If patient is currently taking opioids or getting Opioid prescription refills, answered as either yes or no and assessed on post operative day 14, at week 6 and week 12 following surgery.

   Time frame: From surgery to post operative day 14 week 6 and week 12

7. Non-opioid analgesic use (Post-Operative Day0-48 hrs, 0-168 hrs, 0-Post-Operative Day14)

   Analgesics used other than opioids on day of surgery, postoperative day 2 (i.e. 48 hrs), day 7 (i.e. 168hrs), and day 14

   Time frame: From day of surgery to 48hours after,168hours after, and 14 days after

8. Study medication discontinuation (% of patients who stopped the placebo/Suzetrigine day 0 through post-op day 14)

   The percentage of patients who patients who stopped taking either the placebo drug or Suzetrigine within the first 14 days following surgery

   Time frame: From surgery to the 14th day post operatively

9. Request for Suzetrigine refill after randomization period

   Number of patients that requested more or a refill of Suzetrigine after the randomization period was over

   Time frame: From date if surgery till until end of study up to 2 years after surgery

10. Patient satisfaction with pain management: @ Post-Operative Day2 and @Post-Operative Day7 and @Post-Operative Day14

    Patients will communicate there satisfaction with how well their pain is controlled this will be assessed 2 days and 7 days and 14 days following surgery. Number on Scale out of 10 (where 0 is not satisfied, 10 is very satisfied).

    Time frame: From date of surgery to 2 days following surgery and then again 7 days following surgery and 14 days following surgery.

11. Pain Interference: @Post-Operative Day2 and @ Post-Operative Day7 and @Post-Operative Day14

    Measuring how much since surgery Pain has interfered with normal day to day activities. This will be self reported using a number Scale (0-10, 0= no interference, 10= significant interference) on postoperative days 2 and 7 and 14. Patients will be asked; how much, since your surgery, has pain interfered with performing activities in bed such as turning, sitting up, and changing position? how much, since your surgery, has pain interfered with walking? how much, since your surgery, has pain interfered with your sleep? how much, since your surgery, has pain interfered with your mood?

    Time frame: From date of surgery to post operative day 2 and 7 and 14

12. KOOS, JR @ 6 weeks

    Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR) is a 0-100 scale that assesses hip pain and function, where a higher score indicates better hip health and a lower score indicates greater disability. This will be assessed preoperatively within 30 days of the surgery and then again 6 weeks post operatively. This measure will be extracted via EPIC or by a patient reported survey if not filled out in EPIC/mychart.

    Time frame: Up to 30 days preoperatively to 6 weeks following surgery

13. Sleep quality & @preop, Post-Operative Day7 and Post-Operative Day14 (questionnaire asks about sleep quality/duration over the past week)

    Sleep quality will be assessed using patient-reported questionnaires that evaluate sleep patterns over the preceding week. Assessments will be completed preoperatively and on postoperative days 7 and 14. Outcomes will include overall sleep quality rating and average sleep duration in hours per night.

    Time frame: Pre-op and Post-Operative Day (POD)7 and Post-Operative Day (POD)14

14. Incidence of adverse invents (Post-Operative Day0-14)

    Unexpected adverse events, that may occur to the patient after administration of Suzetrigine from the date the medication is given to the 14th day following surgery using Common Terminology Criteria for Adverse Events (CTCAE) v6.0 (MedDRA 28.0) grading system Grade 1 Mild; Grade 2 Moderate; Grade 3 Severe or medically significant; Grade 4 Life-threatening consequences; Grade 5 Death related to AE. for Nausea, Vomiting, Constipation, Difficulty passing urine, Concentrating, Somnolence, Lightheaded/dizziness, Confusion, Fatigue, Pruritis, Headache, Dry mouth, Paresthesia, Muscle spasm, Rashes, Problems with sleep, Delirium, Abnormal lab values, Other Patient-reported adverse effects (diarrhea, changes to heart beat/arrythmias, blurred vision, low blood pressure, difficulty breathing, hives, swelling of the face/lips/tongue/extremities/throat, other)

    Time frame: From the date the medication is given to the post operative day 14.

15. Patient expectation of Suzetrigine @preop

    Patient expectations regarding the effectiveness of Suzetrigine for postoperative pain management will be assessed prior to surgery using a questionnaire. Patients will report their anticipated level of pain relief, improvement in function, reduction in opioid requirements, and overall confidence in the medication.

    Time frame: Pre-op

16. Block duration assessed @Post-Operative Day1, (or Post-Operative Day2 or until full resolution)

    Duration of peripheral nerve block will be assessed from the time of block administration until complete resolution of sensory and motor blockade. Resolution will be determined through patient report and clinical assessment of return of normal sensation and motor function.

    Time frame: Postoperative day 1 or until complete resolution of sensory and motor blockade assessed for up to 14 days postoperatively

17. Range of Motion (ROM) @week 6

    Knee range of motion (ROM) will be measured at 6 weeks following surgery using standard clinical assessment techniques. ROM will be recorded in degrees and include measurements of both knee flexion and extension. Higher flexion and lower extension deficits indicate improved postoperative joint function.

    Time frame: 6 weeks post operative

18. Rate of manipulation under anesthesia (MUA) through 6 weeks and through 12 weeks

    The rate of manipulation under anesthesia (MUA) performed for postoperative knee stiffness will be recorded through 6 weeks and 12 weeks after surgery. Incidence will be reported as the proportion of patients requiring MUA during the follow-up period.

    Time frame: Day of surgery to 12 weeks post-surgery

19. duration @preop, Post-Operative Day7 and Post-Operative Day14 (questionnaire asks about sleep quality/duration over the past week)

    Sleep duration will be assessed using patient-reported questionnaires that evaluate sleep patterns over the preceding week. Assessments will be completed preoperatively and on postoperative days 7 and 14. Outcomes will include overall sleep quality rating and average sleep duration in hours per night.

    Time frame: Preop, Post-Operative Day (POD)7 and Post-Operative Day (POD) 14

Individual participant data

Plan to share: Yes — Requests for de-identified research data should be directed to the principal investigator Meghan Kirksey, MD, PhD at the email address: KirkseyM@hss.edu. A fully executed data use agreement between Hospital for Special Surgery and the requesting institution is required prior to data sharing.