Tramadol-paracetamol for postoperative pain after spine surgery – A randomized, double-blind, placebo-controlled study

Abstract Objectives Multimodal pain management is one component in enhanced recovery after surgery protocol. Here we evaluate the efficacy of tramadol–paracetamol in acute postoperative pain and pain outcome at 12 months after spine surgery in randomized, double-blind, placebo-controlled trial. Methods We randomized 120 patients undergoing spine surgery to receive, for add-on pain management, two tramadol–paracetamol 37.5 mg/325 mg (n = 61) or placebo tablets (n = 59) twice a day for 5 postoperative days. In the hospital, multimodal pain management consisted of dexketoprofen and oxycodone. After discharge, patients were prescribed ibuprofen 200 mg, maximum 1,200 mg/day. Pain, analgesic use, and satisfaction with pain medication were followed up with the Brief Pain Inventory questionnaire before surgery and at 1 and 52 weeks after surgery. The primary outcome was patients’ satisfaction with pain medication 1 week after surgery. Results At 1 week after surgery, patients’ satisfaction with pain medication was similarly high in the two groups, 75% [interquartile range, 30%] in the placebo group and 70% [40%] in the tramadol–paracetamol group (p = 0.949) on a scale: 0% =  not satisfied, 100% = totally satisfied. At 1 week, ibuprofen dose was lower in the placebo group 200 mg [1,000] compared to the tramadol–paracetamol group, 800 mg [1,600] (p = 0.016). There was no difference in the need for rescue oxycodone. Patients in the tramadol–paracetamol group had more adverse events associated with analgesics during the first postoperative week (relative risk = 1.8, 95% confidence interval, 1.2–2.6). Conclusion Add-on pain treatment with tramadol–paracetamol did not enhance patients’ satisfaction with early pain management after back surgery.