Abstract
Evidence for adding dexketoprofen trometamol to sufentanil-based patient-controlled intravenous analgesia (PCIA) after thoracoscopic radical resection of lung cancer remains limited. To evaluate 48-hour opioid consumption, pain outcomes, and short-term adverse events with dexketoprofen trometamol plus sufentanil versus sufentanil-based PCIA alone. In this randomized, double-blind, placebo-controlled trial, 108 patients scheduled for thoracoscopic radical resection of lung cancer were randomized preoperatively (54 per group). After 18 post-randomization exclusions before PCIA initiation, 45 patients per group received the allocated intervention and were analyzed. All underwent unilateral uniportal anatomical segmentectomy with mediastinal lymph node dissection or sampling and received a standardized intercostal nerve block. Group S received sufentanil-based PCIA, and Group R additionally received dexketoprofen trometamol. The primary outcome was total 48-hour postoperative sufentanil consumption, including rescue doses. Sufentanil consumption was lower in Group R than in Group S (78.03 ± 10.66 vs 96.78 ± 13.69 μg; reduction 18.75 μg, 95% CI 13.61 to 23.89; P<0.001), representing an approximately 19% reduction. Resting pain scores were lower at 12 and 24 hours (both P=0.004), meeting the revised Bonferroni threshold of P<0.005 for 10 time-point comparisons; the coughing-pain difference at 12 hours (P=0.006) did not meet this threshold. Resting-pain area under the curve was lower (P=0.009), but generalized estimating equations showed no significant overall group effect or group-by-time interaction for resting or coughing pain. Nausea occurred in 11.1% versus 28.9% (Pearson χ2 P=0.035). Adding dexketoprofen trometamol reduced 48-hour sufentanil consumption in the analyzed population. Pain differences were time-specific secondary findings and did not establish sustained analgesic superiority. The nausea finding requires confirmation, and the trial was insufficient to establish safety for uncommon adverse events.