ANALGESIA PREEMPTIVA COM PREGABALINA EM CIRURGIA CARDÍACA: ENSAIO CLÍNICO RANDOMIZADO PREGABA-HEART STUDY

Abstract

Post-sternotomy pain occurs in about 50% of patients undergoing cardiac surgery. However, 50% to 75% do not receive adequate analgesic management, impairing efficient spontaneous ventilation, respiratory toilet, and patient mobilization, thereby increasing the risk of atelectasis, healthcare-related pneumonia, and thromboembolic events. Preemptive analgesia is initiated before the painful stimulus is generated, aiming to prevent or reduce subsequent pain. Methods. A phase 3, triple-blind, placebo-controlled clinical trial randomizing adults aged 18 to 80 years to receive Pregabalin 75 mg or placebo 1 hour before cardiac surgery and every 12 hours until postoperative day 2 (POD). The Visual Analog Scale (VAS) of pain, vital signs, arterial blood gas, quality of post-anesthesia recovery (QoR-40), and incidence of adverse events from the 1st to the 3rd POD were collected. The significance level used was 0.05. Results. 109 patients were included, randomized to pregabalin (n = 56) or placebo (n = 53). The intervention did not affect mean VAS at each POD, but caused a significant reduction in VAS from 1st to 2nd POD of 1,167 points (95% CI 0.401 - 1,933, p = 0.039) and from 1st to 3rd POD of 1,738 points (95% CI 0.972 - 2.504, p <0.001). There was no difference in analgesic consumption, clinical and laboratory parameters, QoR-40 or incidence of adverse events between groups. Age (r = -0.388, p < 0.001), weight (r = 0.361, p < 0.001), BMI (r = 0.314, p = 0.002), DBP (r = 0.327, p = 0.002) and MAP (0.305, p = 0.003) were weakly but significantly correlated to VAS at 1st PO day. Conclusion. Pregabalin was associated with a reduction in pain from 1st to 2nd and 3rd PODs of cardiac surgery, with adequate safety. Aggregating this study with previous studies may accurately estimate the magnitude of pregabalin's effect on postoperative pain in cardiac surgery, and a protocol with 150 mg may outline a greater magnitude of the drug's effect.