End-stage knee osteoarthritis or rheumatoid arthritis scheduled for primary unilateral total knee arthroplasty
Conditions
Interventions
Transdermal fentanyl patch group:One transdermal fentanyl patch releasing fentanyl at 25 micrograms per hour will be applied at 20:00 on the evening before surgery and removed on the
Placebo patch group:One placebo transdermal patch identical in appearance but without active ingredient will be applied at 20:00 on the evening before surgery and removed
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
45 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Aged 45 to 80 years, male or female; 2.Diagnosed with end-stage knee osteoarthritis or rheumatoid arthritis and scheduled for elective primary unilateral total knee arthroplasty at West China Hospital, Sichuan University; 3.American Society of Anesthesiologists physical status I to III; 4.Body mass index 18 to 35 kg/m^2; 5.No long-term opioid use within 3 months before surgery, defined as oral morphine equivalent dose less than 10 mg per day and continuous use for less than 7 days; 6.Able to understand the 0 to 10 numerical rating scale and cooperate with pain and functional follow-up assessments; 7.Voluntarily participates in the study and signs written informed consent.
Exclusion criteria
Exclusion criteria: 1.Known severe allergy or adverse reaction to fentanyl, other opioids, or patch excipients; 2.History of opioid dependence, abuse, or addiction to other psychoactive substances; 3.Significant cognitive impairment, severe psychiatric disorder, or impaired consciousness preventing reliable pain reporting or compliance; 4.Severe hepatic insufficiency or severe renal insufficiency; 5.Moderate to severe chronic obstructive pulmonary disease, untreated severe sleep apnea syndrome, other conditions significantly increasing the risk of respiratory depression, or known/suspected gastrointestinal obstruction; 6.Acute myocardial infarction, acute cerebrovascular event, or other unstable cardiovascular or cerebrovascular events within the past 3 months; 7.Planned use of continuous peripheral nerve block or other analgesic methods that may significantly affect postoperative pain or opioid consumption evaluation; 8.Pregnant or lactating women; 9.Participation in another interventional clinical trial; 10.Other conditions judged by the investigator as unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve of postoperative 0 to 48-hour numerical rating scale pain scores; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall satisfaction score before discharge;Knee function scores;Range of motion of the knee joint;Length of hospital stay;Discharge destination;Change in knee circumference;Maximum postoperative walking distance;Mid- and long-term postoperative pain score;Cumulative postoperative opioid consumption;Postoperative analgesic use;Patient-reported knee functional recovery score;Postoperative nighttime pain score;Inflammatory markers;Local condition of the operated knee;Time to first mobilization;Adverse reactions and safety events; | — |
Countries
China
Contacts
Public ContactZongke Zhou
West China Hospital of Sichuan University
Outcome results
None listed