Suzetrigine for Postoperative Pain After Total Ankle Replacement
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSoheil Ashkani Esfahani
About this trial
This study is testing whether adding a non-opioid pain medicine called suzetrigine (Journavx) to the usual combination of pain medicines helps people recover more comfortably after ankle replacement surgery.
Adults aged 18 to 75 who are scheduled for a first-time total ankle replacement may join. Everyone who joins will receive suzetrigine in addition to their usual pain medicines. Study visits happen at the same times as normal follow-up appointments after surgery.
At these visits, participants will rate their pain, answer questionnaires about how pain affects daily life, mood, and physical activity, report how much pain medicine they have taken, report any side effects, and have their ankle motion measured.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients aged 18-75 years
Undergoing primary total ankle arthroplasty (TAA)
Capable of completing study questionnaires
Capable of providing informed consent for enrollment
Disqualifiers
Declines to participate or discontinues participation during the study
Body mass index (BMI) ≥50 kg/m²
Preoperative or current opioid use
Prior history of ipsilateral ankle infection
Trial design
Design model
Single group
Treatments tested in this trial
Suzetrigine
DrugOral suzetrigine administered postoperatively in addition to standard multimodal analgesia.
Treatment groups
28 Participants
are divided into 1 treatment groupGroup A: GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Cumulative Postoperative Opioid Consumption Through Postoperative Day 14
Cumulative opioid consumption will be calculated as the total amount of opioid medication used from postoperative day 0 through postoperative day 14 and converted to morphine milligram equivalents (MME). Higher MME values indicate greater opioid consumption.
Time frame
Postoperative day (POD) 0 through Postoperative Day 14Secondary outcomes
1
Pain Intensity Assessed by the Numeric Pain Rating Scale (NPRS)
Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher NPRS scores indicate greater pain intensity.
Time frame
24 hours, 2 weeks, 1 month, 3 months, and 6 months after surgery2
Pain Interference Assessed by PROMIS Pain Interference 6b
Pain interference will be assessed using the Patient-Reported Outcomes Measurement Information System Short Form v1.0 - Pain Interference 6b (PROMIS Pain Interference 6b). The instrument contains 6 items assessing the extent to which pain interferes with activities and aspects of daily life. Raw scores range from 6 to 30 and are converted to standardized T-scores ranging from 41.0 to 78.3. Higher scores indicate greater pain interference and a worse outcome.
Time frame
24 hours, 2 weeks, 1 month, 3 months, and 6 months after surgery3
Pain Intensity Assessed by PROMIS Pain Intensity 3a
Pain intensity will be assessed using the Patient-Reported Outcomes Measurement Information System Scale v1.0 - Pain Intensity 3a (PROMIS Pain Intensity 3a). The instrument contains 3 items assessing worst pain, average pain, and current pain. Raw scores range from 3 to 15 and are converted to standardized T-scores ranging from 36.3 to 81.8. Higher scores indicate greater pain intensity and a worse outcome.
Time frame
24 hours, 2 weeks, 1 month, 3 months, and 6 months after surgery4
Physical Function Assessed by PROMIS Physical Function 10a
Physical function will be assessed using the Patient-Reported Outcomes Measurement Information System Short Form v2.0 - Physical Function 10a (PROMIS Physical Function 10a). The instrument contains 10 items assessing the ability to perform physical activities and activities of daily living. Raw scores range from 10 to 50 and are converted to standardized T-scores ranging from 13.5 to 61.9. Higher scores indicate better physical function and a better outcome.
Time frame
24 hours, 2 weeks, 1 month, 3 months, and 6 months after surgeryLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Soheil Ashkani Esfahani
Lead sponsor
Massachusetts General Hospital
Sponsor institution
Vertex Pharmaceuticals Incorporated
Collaborator
Source ClinicalTrials.gov
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