Prospective Randomized Study Evaluating the Effect of Postoperative Ketorolac on Bone Healing and Opioid Consumption after First Metatarsophalangeal Joint Fusion

Abstract

Category: Midfoot/Forefoot Introduction/Purpose: Amid the opioid crisis, the use of non-narcotic pain medication post-operatively has garnered increased interest. Nonsteroidal anti-inflammatory drugs (NSAIDs) have the potential to serve as an adjunct treatment to opioid medications in the post-operative period but have been viewed with hesitancy due to associations with delayed bone healing. This prospective randomized study aimed to evaluate the use of ketorolac on postoperative pain, opioid requirements, patient satisfaction, complication/reoperation rates, and delayed and/or nonunion rates in patients undergoing fusion of their first metatarsophalangeal joint (1st MTPJ) for treatment of end-stage arthritis. We hypothesized that the use of postoperative ketorolac would decrease opioid medication use and improve patient satisfaction with regards to their pain control, while having no effect on clinical or radiographic healing. Methods: Eighty-eight patients undergoing 1st MTPJ fusion were randomized before surgery to treatment with or without ketorolac for 5 days after surgery. A once-daily survey was distributed via email on postoperative days (POD) 1-7. Unblinded participants were asked to report opioid consumption, VAS pain level, satisfaction with pain management using a 6-point Likert scale, perceived frequency of pain using a 5-point Likert scale, pain interference with sleep, and side effects using VAS. Clinical healing was assessed by the treating surgeon based on patient's ability to ambulate comfortably at 12 weeks post-operatively. Radiographic healing at 12-weeks was assessed by two fellowship-trained orthopedic foot and ankle surgeons blinded to the patient's name and cohort assignment. Intention-to-treat analysis was performed. Results: Seventy-two patients completed at least 4 out of the 7 postoperative surveys. Average was 60.7 +- 8.39 years with 58.3% female (42/72), and a mean BMI of 28.6 +- 5.77. Between groups, there were no significant differences in age, BMI, sex, smoking status, inflammatory arthritis, or diabetes (p>0.05). Across all POD, there were no significant differences in VAS-pain scores and satisfaction with pain management. Morphine milligram equivalents (MME) consumed (36.2 +- 24.7 vs. 26.2 +- 24.2, p=0.119) and number of opioid pills taken (5.78 +- 2.86 vs. 3.93 +- 2.06, p=0.055) were slightly, but not significantly, lower among patients who received ketorolac on POD 2. There were no differences in MME consumed on the other postoperative days. Overall, 94.4% (68/72) returned for 12-week radiographic evaluation and there were no differences in radiographic healing between the two groups with a Kappa-Fleiss value of 0.559, indicating moderate agreement between reviewers. Conclusion: The use of postoperative ketorolac led to slightly, but not significantly, less opioid consumption in the acute postoperative period following 1st MTPJ fusion, while not causing a negative effect on radiographic healing of the fusion at 12- weeks postoperatively.