A comparative study of efficacy and safety of flupirtine versus piroxicam in postoperative pain in patients undergoing lower limb surgery

BACKGROUND: Effective control of pain postoperatively is essential in providing enhanced patient care and a cost-effective hospital stay. Though many treatment modalities exist for postoperative pain management in orthopedic surgeries they are often accompanied by adverse effects. This study was carried out to assess the efficacy of flupirtine and piroxicam in postoperative pain reduction using visual analog scale (VAS) score. MATERIALS AND METHODS: An open-label, parallel group, comparative study was conducted on patients undergoing lower limb orthopedic surgery, randomized into two groups of 38 patients each. They received either flupirtine 100 mg or piroxicam 20 mg 6 hours after surgery and then twice daily orally for 5 days. Pain was measured using VAS score, total pain relief score (TOTPAR(24)), and patient satisfaction score (PSS); the other scales used were behavioral pain assessment scale (BPAS) and functional activity score (FAS). Rescue medication used was tramadol 100 mg intravenously. WHO causality scale was used for assessing adverse effects. Descriptive and inferential statistics were used for assessment of various parameters. RESULTS: A total of 76 patients with mean ± standard deviation age of 35.08±10.3 years were recruited; 34 in the flupirtine and 37 in the piroxicam groups completed the study. Patients in both groups were comparable in baseline characteristics. Flupirtine and piroxicam reduced VAS score 48 hours postoperatively compared to baseline (p=0.006 and 0.001) and piroxicam produced significant reduction in pain at 8, 12, and 120 hours compared to flupirtine (p=0.028, 0.032, 0.021). TOTPAR(24) and PSS at 24 hours were comparable between the treatments. BPAS scores at 24 hours were reduced significantly in patients receiving either drug (p=0.001). FAS improved at 72 hours in patients receiving piroxicam. Adverse effects were similar with both the medications. CONCLUSION: Flupirtine and piroxicam reduced pain effectively but the onset of pain relief was earlier with piroxicam.