OBJECTIVE: The present study was performed to evaluate the effect of postoperative administration of pregabalin in patients who reported moderate-to-severe pain after epidural analgesia following thoracotomy. DESIGN: An open-label, randomized, controlled, parallel-group study. SETTING:A single center in Japan. PARTICIPANTS: Consecutive patients (aged≥20 years) who reported moderate-to-severe pain after effectual 2-day epidural analgesia post-thoracotomy for lung cancer from February 2012 to March 2013. INTERVENTIONS: Patients were assigned to 2 groups: control (control treatment: acetaminophen, 400 mg, and codeine phosphate powder, 20 mg) or pregabalin (pregabalin, 75 mg, plus control treatment). The 12-week study period included 2-week study treatment and 10-week follow-up. MEASUREMENTS AND MAIN RESULTS: For efficacy, the primary endpoint was the visual analog scale (VAS) scores for pain at rest and with coughing at week 2, and secondary endpoints were the VAS scores for pain and the neuropathic pain questionnaire at week 12. Fifty patients were randomized (25 per group). At week 2, the VAS scores for pain at rest (mean [SD]) were 29.5 (21.9) in the control group and 16.3 (15) in the pregabalin group (p = 0.02); for pain with coughing, the scores were 45.2 (20.9) and 28.8 (25.9), respectively (p = 0.02). VAS scores improved more in the pregabalin group than in the control group over the 12 weeks. Patients free from possible neuropathic pain were 48% of the control group and 88% of the pregabalin group, respectively (p = 0.001). CONCLUSIONS: Postoperative administration of pregabalin effectively reduced post-thoracotomy pain.
RCT Entities:
OBJECTIVE: The present study was performed to evaluate the effect of postoperative administration of pregabalin in patients who reported moderate-to-severe pain after epidural analgesia following thoracotomy. DESIGN: An open-label, randomized, controlled, parallel-group study. SETTING: A single center in Japan. PARTICIPANTS: Consecutive patients (aged≥20 years) who reported moderate-to-severe pain after effectual 2-day epidural analgesia post-thoracotomy for lung cancer from February 2012 to March 2013. INTERVENTIONS:Patients were assigned to 2 groups: control (control treatment: acetaminophen, 400 mg, and codeine phosphate powder, 20 mg) or pregabalin (pregabalin, 75 mg, plus control treatment). The 12-week study period included 2-week study treatment and 10-week follow-up. MEASUREMENTS AND MAIN RESULTS: For efficacy, the primary endpoint was the visual analog scale (VAS) scores for pain at rest and with coughing at week 2, and secondary endpoints were the VAS scores for pain and the neuropathic pain questionnaire at week 12. Fifty patients were randomized (25 per group). At week 2, the VAS scores for pain at rest (mean [SD]) were 29.5 (21.9) in the control group and 16.3 (15) in the pregabalin group (p = 0.02); for pain with coughing, the scores were 45.2 (20.9) and 28.8 (25.9), respectively (p = 0.02). VAS scores improved more in the pregabalin group than in the control group over the 12 weeks. Patients free from possible neuropathic pain were 48% of the control group and 88% of the pregabalin group, respectively (p = 0.001). CONCLUSIONS: Postoperative administration of pregabalin effectively reduced post-thoracotomy pain.