Comparison of Suzetrigine and Oxycodone for Postoperative Pain After Primary Total Knee Arthroplasty
- Conditions
- Osteoarthritis (OA) of the Knee
- Interventions
- Drug: oral suzetrigine
- Registration Number
- NCT07219888
- Lead Sponsor
- University of Louisville
- 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 140
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A: suzetrigine group oral suzetrigine 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 oral Oxycodone Participant will receive a two-week supply of oral Oxycodone upon discharge
- Primary Outcome Measures
Name Time Method Daily Opioid Use POD 1-14 2 weeks Daily opioid use as measured in MME recorded daily for the first two weeks following TKA
total opioid usage over two weeks 2 weeks total daily opioid usage (as measured in MME) for the first 14 days following TKA
Use of supplemental opioid POD 1-14 2 weeks Average time from initial preop pain control dose to first postop supplemental opioid dose (for participants randomized to Group A, if applicable)
VAS pain score over two weeks 2 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
Opioid Usage at 6 weeks postop 6 weeks Usage of opioids at 6 weeks postoperatively (Y/N) and if yes, what is daily usage
- Secondary Outcome Measures
Name Time Method KOOS, JR. preoperatively and 6 weeks (± 2 weeks) postoperatively 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.
VAS Pain Score at 6 weeks 6 weeks VAS (Visual Analogue Scale) pain score measuring highest level of knee pain at 6 weeks following TKA. Scale 0-10
ROM preoperatively, 2 weeks and 6 weeks (± 2 weeks) postoperatively active range-of-motion (ROM) as measured in degrees of extension and degrees of flexion