UofL Health
Louisville, Kentucky, 40202, United States
NCT Number: NCT07219888
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.
Interested in participating?
Request Info21 year–89 year
All sexes
Interventional
Phase 4
Louisville, Kentucky, 40202, United States
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:
Participants will:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
patient receives a two-week supply of oral suzetrigine upon discharge
Patient will receive a two-week supply of oral Oxycodone upon discharge
Time frame: 2 weeks
Daily opioid use as measured in MME recorded daily for the first two weeks following TKA
Time frame: 2 weeks
total daily opioid usage (as measured in MME) for the first 14 days following TKA
Time frame: 2 weeks
Average time from initial preop pain control dose to first postop supplemental opioid dose (for participants randomized to Group A, if applicable)
Time frame: 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
Time frame: 6 weeks
Usage of opioids at 6 weeks postoperatively (Y/N) and if yes, what is daily usage
Time frame: 6 weeks
VAS (Visual Analogue Scale) pain score measuring highest level of knee pain at 6 weeks following TKA. Scale 0-10
Time frame: 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.
Time frame: preoperatively, 2 weeks and 6 weeks (± 2 weeks) postoperatively
active range-of-motion (ROM) as measured in degrees of extension and degrees of flexion
University of Louisville
Other
Comparison of Suzetrigine and Oxycodone for Postoperative Pain and Analgesic Requirements After Primary Total Knee Arthroplasty: a Prospective, Randomized Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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