Comparison of Suzetrigine and Oxycodone for Postoperative Pain After Primary Total Knee Arthroplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: oral suzetrigine, oral Oxycodone.
- Who it may be relevant to
- Registry conditions: Osteoarthritis (OA) of the Knee. Basic parameters: 21 years — 89 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Suzetrigine and Oxycodone for Postoperative Pain and Analgesic Requirements After Primary Total Knee Arthroplasty: a Prospective, Randomized Study
Overview
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.
Detailed description
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:
1. What is the efficacy of oral suzetrigine in reducing opioid consumption and postoperative pain following primary total knee arthroplasty? 2. Will the study results demonstrate the effectiveness and safety of oral suzetrigine after primary total knee arthroplasty in reducing postoperative opioid usage while maintaining a similar or better level of pain control when compared to a standard pain control regimen? Researchers will compare suzetrigine to a standard postoperative pain control regimen (Oxycodone) to see if suzetrigine is equivalent or more effective at reducing opioid consumption and postoperative pain following primary total knee arthroplasty.
Participants will:
* be randomized into one of two groups * undergo a primary TKA * complete a tracking sheet documenting daily pain medicine usage and VAS pain level for the first 14 days following the TKA * return to office at 2 weeks and 6 weeks postop for follow-up * complete additional questionnaires at 2 weeks and 6 weeks postop
Interventions
- Drug oral suzetrigine
patient receives a two-week supply of oral suzetrigine upon discharge - Drug oral Oxycodone
Patient will receive a two-week supply of oral Oxycodone upon discharge
Primary outcome measures
- Daily Opioid Use POD 1-14 [Time frame: 2 weeks]
- total opioid usage over two weeks [Time frame: 2 weeks]
- Use of supplemental opioid POD 1-14 [Time frame: 2 weeks]
- VAS pain score over two weeks [Time frame: 2 weeks]
- Opioid Usage at 6 weeks postop [Time frame: 6 weeks]
Secondary outcome measures (3)
- VAS Pain Score at 6 weeks [Time frame: 6 weeks]
- KOOS, JR. [Time frame: preoperatively and 6 weeks (± 2 weeks) postoperatively]
- ROM [Time frame: preoperatively, 2 weeks and 6 weeks (± 2 weeks) postoperatively]
Eligibility criteria
Inclusion criteria
- Patient age is 21-89 at time of surgery
- Patient is scheduled to undergo a unilateral primary TKA, secondary to osteoarthritis
- Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization document
- Patient is able to read and speak English.
Exclusion criteria
- Patient is under the age of 21
- Patient's primary diagnosis is not osteoarthritis
- Patient is unable to read and speak English
- Contraindication or Hypersensitivity to suzetrigine
- Pregnant or nursing females
- Patient has taken opioids within the 90 days prior to enrollment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- UofL Health — Louisville
Publications
- 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. PMID 40862032
- 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. PMID 37497399
- 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. PMID 36331523
Identifiers
NCT: NCT07219888 · 25.0688