Effect of 5% lidocaine-medicated plaster in preventing chronic postsurgical pain after knee replacement: protocol for a randomized double-blind placebo-controlled trial
Bibliographic record
Abstract
Background: With an aging population, knee arthroplasty is increasingly common; however, chronic postsurgical pain (CPSP) affects up to 30% of patients. This study aims to evaluate the efficacy of 5% lidocaine-medicated plaster (LP5) in preventing CPSP among patients undergoing knee arthroplasty. Methods: This is a dual-center, randomized, double-blind, placebo-controlled trial involving 128 adult patients scheduled for knee arthroplasty. Participants will be randomly assigned, stratified by center, to either the LP5 group or the placebo group (n = 64 per group). The LP5 or placebo group will apply the patch 1 day before surgery and on postoperative days 1-3, with multimodal analgesia administered postoperatively. Multimodal analgesia will include intraoperative flurbiprofen axetil and postoperative patient-controlled sufentanil. The primary outcome is the pain subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 3 months postoperatively. Secondary outcomes will include WOMAC stiffness, function, and total scales; Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale; 36-Item Short Form Health Survey (SF-36); postoperative pain scores; Visual Analog Scale (VAS) sleep scores; postoperative sufentanil consumption; need for rescue analgesia; length of Post-Anesthesia Care Unit (PACU) stay; length of hospital stay; and 90-day mortality. Safety outcomes will include assessments of hypotension, hypertension, bradycardia, tachycardia, arrhythmia, interventions for haemodynamic events, headache, dizziness, nausea, vomiting, local skin allergy, wound infection, and toxic reaction. Data will be analyzed following a modified intention-to-treat approach. Discussion: This study aims to provide high-quality evidence for the efficacy and safety of LP5 in preventing CPSP in patients undergoing knee arthroplasty.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.022 | 0.022 |
| Meta-epidemiology (narrow) | 0.007 | 0.003 |
| Meta-epidemiology (broad) | 0.013 | 0.005 |
| Bibliometrics | 0.002 | 0.003 |
| Science and technology studies | 0.004 | 0.004 |
| Scholarly communication | 0.004 | 0.003 |
| Open science | 0.004 | 0.002 |
| Research integrity | 0.008 | 0.008 |
| Insufficient payload (model declined to judge) | 0.058 | 0.009 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".