OBJECTIVE: A pilot study was conducted to assess whether both the rationale and feasibility exist for future randomized clinical trials to evaluate the combined use of naloxone infusion and tramadol/acetaminophen as opioid-sparing drugs in elderly patients undergoing lower extremity joint replacement surgery.DESIGN: Ten patients 70 years of age or older undergoing either total knee (n=7) or total hip (n=3) arthroplasty were treated prospectively. Each patient received two tablets of tramadol/acetaminophen (Tramacet; Janssen-Ortho Inc, Canada) preoperatively and every 6 h postoperatively, as well as a naloxone infusion started preoperatively at 0.25 μg/kg/h and continued up to 48 h postoperatively. In addition, standard intraoperative care was provided with 0.2 mg of intrathecal morphine, 1.4 mL of 0.75% bupivacaine, and an intra-articular infiltration of 100 mL of 0.3% ropivacaine and 30 mg of ketorolac, as well as standard postoperative morphine via patient-controlled analgesia orders and celecoxib 200 mg twice daily for five days.OUTCOME MEASURES: Compared with seven historical controls, also 70 years of age or older, who had undergone either a total knee (n=4) or total hip (n=3) arthroplasty, postoperative opioid use was reduced by 80%. Except for transient nausea and vomiting in 40% and 20% of patients, respectively, the 10 patients on tramadol/acetaminophen and naloxone tolerated the new regimen without difficulty.CONCLUSION: Consequently, a randomized, double-blinded clinical trial comparing standard therapy versus standard therapy plus these two drugs seems warranted. In such a trial, it would require approximately 20 subjects per treatment arm to detect a 80% decrease in morphine use.