Comparison of Suzetrigine and Oxycodone for Postoperative Pain After Primary Total Knee Arthroplasty

NCT ID: NCT07219888

Last Updated: 2025-10-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2026-05-29

Brief Summary

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

Conditions

Osteoarthritis (OA) of the Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Group A: suzetrigine group

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 Type: EXPERIMENTAL

oral suzetrigine

Intervention Type: DRUG

patient receives a two-week supply of oral suzetrigine upon discharge

Group B: Oxycodone group

Participant will receive a two-week supply of oral Oxycodone upon discharge

Group Type: ACTIVE_COMPARATOR

oral Oxycodone

Intervention Type: DRUG

Patient will receive a two-week supply of oral Oxycodone upon discharge

Interventions

oral suzetrigine

patient receives a two-week supply of oral suzetrigine upon discharge

Intervention Type: DRUG

oral Oxycodone

Patient will receive a two-week supply of oral Oxycodone upon discharge

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patient age is 21-89 at time of surgery

2. Patient is scheduled to undergo a unilateral primary TKA, secondary to osteoarthritis

3. Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization document

4. Patient is able to read and speak English.

Exclusion Criteria

1. Patient is under the age of 21

2. Patient's primary diagnosis is not osteoarthritis

3. Patient is unable to read and speak English

4. Contraindication or Hypersensitivity to suzetrigine

5. Pregnant or nursing females

6. Patient has taken opioids within the 90 days prior to enrollment

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Arthur Malkani

Clinical Professor, Chief, Adult Reconstruction

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rodolfo Zamora, MD

Role: STUDY_CHAIR

University of Louisville

Central Contacts

Langan S Smith, BS

Role: CONTACT

langan.smith@uoflhealth.org

502-587-8222 ext. 65585

Libbee Galloway, MS

Role: CONTACT

libbee.galloway@uoflhealth.org

5025878222

References

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.

Reference Type: RESULT

PMID: 40862032 (View on PubMed)

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.

Reference Type: RESULT

PMID: 37497399 (View on PubMed)

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.

Reference Type: RESULT

PMID: 36331523 (View on PubMed)

Other Identifiers

25.0688

Identifier Type: -

Identifier Source: org_study_id