A transdermal esflurbiprofen patch provided post-operative pain control that was noninferior to oral celecoxib in patients undergoing total knee arthroplasty, with similar pain scores, functional recovery, and safety outcomes through 6 weeks of follow-up.
“Although several studies have proven the efficacy of transdermal NSAIDs in KOA [knee osteoarthritis], the established role for their efficacy in post-operative pain control and safety after TKA [total knee arthroplasty] is limited,” researchers in Thailand wrote in their single-center, prospective, randomized controlled noninferiority trial, published in Arthroplasty.
For the trial, investigators enrolled 100 patients aged 50 years or older who were undergoing primary unilateral total knee arthroplasty for knee osteoarthritis. They randomly assigned participants in a 1:1 ratio to receive either a 40 mg transdermal esflurbiprofen patch applied once daily or oral celecoxib 200 mg once daily for 14 days, beginning on postoperative day 1. All patients received the same multimodal pain management regimen, including paracetamol, pregabalin, a continuous adductor canal block, and an infiltration between the popliteal artery and the posterior capsule of the knee.
The study’s primary endpoint was pain intensity on postoperative day 14, as measured by the visual analog scale . Participants had a mean age of 72 years, and more than 70% were women. Researchers assigned 50 patients to each treatment group, and all participants completed the 6-week follow-up.
Pain scores improved significantly from baseline in both groups throughout follow-up. By postoperative day 14, average pain scores at rest were 1.0 in the transdermal esflurbiprofen group and 0.8 in the oral celecoxib group. Average pain scores with movement were 2.5 and 2.3, respectively. The differences between groups were small enough to show that the esflurbiprofen patch worked about as well as oral celecoxib for pain control. No patients in either group needed rescue morphine.
Pain levels followed a similar pattern in both groups. Average pain scores during movement started at 5.3 in both groups and fell to 2.0 in the transdermal esflurbiprofen group and 1.8 in the oral celecoxib group by week 6. Average pain scores at rest also improved, decreasing from 3.4 at baseline in both groups to 0.6 in the transdermal group and 0.5 in the celecoxib group at week 6.
Recovery of physical function was similar in both groups. Measures of mobility and strength worsened at 2 weeks after surgery, as expected, but improved by week 6. Researchers found no significant differences between the groups on the Timed Up and Go Test, Five Times Sit to Stand Test, or Three-Minute Walk Test at any time point. Patient-reported outcomes also improved in both groups. Scores on the Western Ontario and McMaster Universities Osteoarthritis Index improved significantly by postoperative day 3 and continued to improve through week 6, with no significant differences between the groups.
Safety outcomes were similar in both groups. Researchers monitored kidney function at baseline, postoperative day 1, week 2, and week 6 and found no meaningful changes over time or significant differences between the treatment groups. No serious adverse events were reported, and no patients discontinued treatment because of application-site skin reactions or other adverse effects.
The researchers noted several limitations, including the study’s open-label design, small sample size, and relatively short 14-day treatment period. These factors may have made it harder to identify rare side effects or adverse events that develop over a longer period. They said larger studies with longer follow-up and more rigorous study designs could help confirm the findings.
No external funding was reported. One author serves on the editorial board of Arthroplasty but was not involved in review or publication decisions related to the manuscript. The authors reported no other competing interests.
Source: Arthroplasty