Suzetrigine for Postoperative Pain After Total Ankle Replacement

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.

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.

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.

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.

Pain intensity will be assessed using the Visual Analog Scale (VAS). Possible scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity and a worse outcome.

Patient satisfaction with postoperative pain management will be assessed using a 6-point Likert scale. Possible scores range from 0 to 5, with higher scores indicating greater satisfaction and a better outcome. Participants will also be asked an open-ended question regarding their experience with suzetrigine; the open-ended response is qualitative and is not included in the numerical satisfaction score.

The number and proportion of participants experiencing one or more adverse events will be recorded. Patient-reported adverse events will be collected using selected items from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), and clinician-reported adverse events will be evaluated using the Common Terminology Criteria for Adverse Events (CTCAE).

Severity of clinician-reported adverse events will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), and patient-reported symptomatic adverse events will be assessed using selected items from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Higher grades or response levels indicate greater adverse-event severity and a worse outcome. PRO-CTCAE consists of individual symptom items and does not produce a single overall composite score.

The proportion of participants who are opioid-free by postoperative day 14 will be determined from recorded postoperative opioid use. Results will be reported as the percentage of participants who are opioid-free at postoperative day 14.

The proportion of participants requiring at least one rescue analgesic because of inadequate pain control will be recorded. Rescue analgesics include medications administered as needed when routine postoperative pain management is insufficient. A higher proportion indicates greater need for additional analgesia.

Baseline risk for opioid use disorder will be assessed using the Opioid Risk Tool for Opioid Use Disorder (ORT-OUD), a 9-item self-report screening instrument. Total scores range from a minimum of 0 to a maximum of 9. Scores of 0-2 indicate lower risk and scores of 3-9 indicate higher risk for future opioid use disorder. Higher scores indicate greater risk and therefore a worse outcome.

Postoperative opioid misuse behaviors will be assessed using the Current Opioid Misuse Measure (COMM), a 17-item self-report instrument. Each item is scored from 0 to 4, producing a total score ranging from a minimum of 0 to a maximum of 68. Higher scores indicate greater evidence of current opioid misuse behaviors and a worse outcome.