Osteoarthritis (OA) of the Knee
Conditions
Keywords
osteoarthritis, knee, total knee arthroplasty, prospective RCT, postoperative analgesia, postoperative pain management
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
Interventions
DRUGoral suzetrigine
patient receives a two-week supply of oral suzetrigine upon discharge
DRUGoral Oxycodone
Patient will receive a two-week supply of oral Oxycodone upon discharge
Sponsors
University of Louisville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Prospective, randomized cohort analysis study
Eligibility
Sex/Gender
ALL
Age
21 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Usage at 6 weeks postop | 6 weeks | Usage of opioids at 6 weeks postoperatively (Y/N) and if yes, what is daily usage |
| 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 |
| Daily Opioid Use POD 1-14 | 2 weeks | Daily opioid use as measured in MME recorded daily for the first two weeks following TKA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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 |
Contacts
Primary ContactLangan S Smith, BS
Backup ContactLibbee Galloway, MS
Outcome results
None listed