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

NCT07219888 | Enrolling By Invitation Phase 4 FDA Drug

• 1 other identifier: 25.0688
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis (OA) of the Knee

Keywords

osteoarthritis; knee; total knee arthroplasty; prospective RCT; postoperative analgesia; postoperative pain management

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (3)

• VAS Pain Score at 6 weeks

  6 weeks

• KOOS, JR.

  preoperatively and 6 weeks (± 2 weeks) postoperatively

• ROM

  preoperatively, 2 weeks and 6 weeks (± 2 weeks) postoperatively

Study Arms (2)

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.

Drug: oral suzetrigine

Group B: Oxycodone group

ACTIVE COMPARATOR

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

Drug: oral Oxycodone

Interventions

oral suzetrigine DRUG

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

Group A: suzetrigine group

oral Oxycodone DRUG

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

Group B: Oxycodone group

Eligibility Criteria

• Age: 21 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

UofL Health

Louisville, Kentucky, 40202, United States

Location

Related Publications (3)

• 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 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.

  PMID: 37497399 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.

  PMID: 36331523 RESULT

MeSH Terms

Conditions

Osteoarthritis

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Rodolfo Zamora, MD

  University of Louisville

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Chief, Adult Reconstruction

Model Details: Prospective, randomized cohort analysis study

Study Record Dates

• First Submitted: October 20, 2025
• First Posted: October 22, 2025
• Study Start: February 9, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)