Background: High post-operative pain scores after ââ?¬Å?minorââ?¬Â orthopedic/trauma surgery are in part attributed to\ninadequate prescription of opioid analgesics. Novel concepts aiming to achieve sufficient analgesia while minimizing\nopioid-related side effects by avoiding fluctuating plasma levels are based on perioperative oral administration of\nextended-release opioids beginning with the first dose pre-operatively. This is the first study to evaluate analgesic\nefficacy and side effect rates of extended-release tapentadol compared to oxycodone/naloxone following orthopedic/\ntrauma surgery.\nMethods: This randomized, observer-blinded, active-controlled prospective clinical trial had 2 co-primary endpoints: (1)\nAnalgesic efficacy: Mean pain level on a numeric rating scale (NRS) from 0 to 10 during exercise over 5 days. (2) Safety:\nSide effect sum score of the following events: Nausea, vomiting, constipation, sedation, vertigo, somnolence. The study\nwas powered to detect superiority of tapentadol for at least one endpoint pending statistical proof of non-inferiority\nfor both endpoints in a first step.\nResults: Two hundred sixty-six trauma patients were randomized to receive either tapentadol (n = 133) or oxycodone/\nnaloxone (n = 133). Analgesic efficacy: Mean (Ã?±SD) daily pain levels in the first five post-operative days were 2.8 Ã?± 1.3 in\nboth groups. Mean maximum pain intensity during exercise in the first 24 h after surgery was 3.8 Ã?± 1.9 (tapentadol) and\n3.8 Ã?± 2.1 (oxycodone/naloxone). Statistically tapentadol was non-inferior but not superior to oxycodone/naloxone.\nSafety: Vomiting on day 1 occurred in 11%, constipation in 35% of the tapentadol patients and in 16% and 30% of the\noxycodone/naloxone patients (p = 0.60 and 0.33), respectively. The incidence of sedation/ vertigo was <10%, that of\nsomnolence <2% in both groups (p > 0.3, respectively). The sum score of side effect events was 51% in the tapentadol\nvs. 49% in the oxycodone/naloxone group; risk difference 3% [95% CI, âË?â??8 to 14%]; p = 0.6). Non-inferiority of\ntapentadol could not be concluded as the pre-defined non-inferiority margin was exceeded.\nConclusions: With both concepts, mean maximum pain intensity during exercise within the first 24 h after orthopedic/\ntrauma surgery was reduced to a score of <4. This analgesic efficacy came at the cost of mainly gastro-intestinal side\neffects. Thus, we now use a prophylaxis against nausea and vomiting and pre-emptive laxatives as part of these\nconcepts.
Loading....