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

University of Louisville (UOFL)

Status and phase: Not yet enrolling; Phase 4

Conditions: Osteoarthritis (OA) of the Knee

Treatments: Drug: oral suzetrigine; Drug: oral Oxycodone

Study type: Interventional

Funder types: Other

Identifiers

NCT07219888

25.0688

Details and patient eligibility

About

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.

Full 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

Enrollment: 140 estimated patients

Sex: All

Ages: 21 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Group A: suzetrigine group

Experimental group

Description:

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.

Treatment:

Drug: oral suzetrigine

Group B: Oxycodone group

Active Comparator group

Description:

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

Treatment:

Drug: oral Oxycodone