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The purpose this study is determine whether postoperative oral dosage of suzetrigine is effective at controlling postoperative pain and reducing analgesic requirements following primary total knee arthroplasty (TKA) versus a control group of TKA patients receiving postoperative Oxycodone.
The purpose of this prospective, randomized study is to compare the outcomes of two cohorts of patients undergoing primary total knee arthroplasty (TKA) and to determine whether postoperative administration of oral dosage of suzetrigine is effective at reducing postoperative pain versus a control group of patients receiving oral dosage of oxycodone only following primary total knee arthroplasty.
The primary objective will be to compare the amount of postoperative narcotics utilized and postoperative VAS pain levels. The secondary objective will be to compare variables of patient functionality and other patient-reported outcome measures.
The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: suzetrigine group | Experimental | Participant will receive a two-week supply of oral suzetrigine upon discharge. Participant will also receive a 10-pill supply of Oxycodone as a rescue medication. |
|
| Group B: Oxycodone group | Active Comparator | Participant will receive a two-week supply of oral Oxycodone upon discharge |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral suzetrigine | Drug | patient receives a two-week supply of oral suzetrigine upon discharge |
|
| Measure | Description | Time Frame |
|---|---|---|
| Daily Opioid Use POD 1-14 | Daily opioid use as measured in MME recorded daily for the first two weeks following TKA | 2 weeks |
| total opioid usage over two weeks | total daily opioid usage (as measured in MME) for the first 14 days following TKA | 2 weeks |
| Use of supplemental opioid POD 1-14 | Average time from initial preop pain control dose to first postop supplemental opioid dose (for participants randomized to Group A, if applicable) | 2 weeks |
| VAS pain score over two weeks | VAS (Visual Analogue Scale) pain score measuring highest level of knee pain experienced each day for the first 14 days following TKA. Scale 0-10 | 2 weeks |
| Opioid Usage at 6 weeks postop | Usage of opioids at 6 weeks postoperatively (Y/N) and if yes, what is daily usage | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| VAS Pain Score at 6 weeks | VAS (Visual Analogue Scale) pain score measuring highest level of knee pain at 6 weeks following TKA. Scale 0-10 | 6 weeks |
| KOOS, JR. | The Knee Injury and Osteoarthritis Outcome Score, Joint Replacement (KOOS, JR) is a survey measuring overall knee health for individuals post total knee arthroplasty (TKA) by evaluating stiffness, pain, function, and activities of daily living. Scoring scale 0-100. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rodolfo Zamora, MD | University of Louisville | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UofL Health | Louisville | Kentucky | 40202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40862032 | Result | Mach M, Giba A, Miedziaszczyk M, Bryla A, Szkutnik-Fiedler D. Suzetrigine as a Novel Non-opioid Analgesic Drug in Pain Management: A Review of Clinical Evidence and Therapeutic Perspectives. Cureus. 2025 Aug 22;17(8):e90755. doi: 10.7759/cureus.90755. eCollection 2025 Aug. | |
| 37497399 | Result | The Lancet Regional Health-Americas. Opioid crisis: addiction, overprescription, and insufficient primary prevention. Lancet Reg Health Am. 2023 Jul 12;23:100557. doi: 10.1016/j.lana.2023.100557. eCollection 2023 Jul. No abstract available. |
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Will not share IPD if it is not a requirement
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D010098 | Oxycodone |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
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Prospective, randomized cohort analysis study
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| oral Oxycodone | Drug | Patient will receive a two-week supply of oral Oxycodone upon discharge |
|
| preoperatively and 6 weeks (± 2 weeks) postoperatively |
| ROM | active range-of-motion (ROM) as measured in degrees of extension and degrees of flexion | preoperatively, 2 weeks and 6 weeks (± 2 weeks) postoperatively |
| 36331523 | Result | Robert M, Jouanjus E, Khouri C, Fouilhe Sam-Lai N, Revol B. The opioid epidemic: A worldwide exploratory study using the WHO pharmacovigilance database. Addiction. 2023 Apr;118(4):771-775. doi: 10.1111/add.16081. Epub 2022 Nov 22. |
| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |