Randomized Controlled Trial of Nonsteroidal Anti-Inflammatory Drugs as a Safe and Effective Alternative to Opioids...

Introduction: This randomized controlled trial aims to demonstrate the noninferiority of nonsteroidal anti-inflammatory drugs (NSAIDs) compared with narcotics for postoperative pain management after percutaneous nephrolithotomy (PCNL), in an era where opioids are commonly utilized. Methods: After institutional review board approval, 85 patients scheduled for PCNL at our institution between May 2023 and January 2025 were consented and randomized to receive either oxycodone (OXY) or ketorolac (KET) for postoperative pain management at home. Inclusion criteria were unilateral, single-access standard PCNL, whereas exclusion criteria included abnormal anatomy, contraindications to KET/OXY, and preexisting stents or nephrostomy tubes. The primary outcome was the Visual Analog Scale (VAS) pain score from postoperative days (PODs) 1-5. Secondary outcomes were recorded on POD 10 office visit and included VAS score, Patient-Reported Outcomes Measurement Information System questionnaire, pill count, office phone calls because of pain, and drug-related adverse events. Complication outcomes were also included as secondary. Results: The cohort had median age of 65 years (interquartile range [IQR]: 49-70), stone burden of 975 mm³ (IQR: 558-2356), STONE score of 6 (IQR: 5-7), and operative time of 66 minutes (IQR: 53-90). Baseline characteristics, including clinical, stone, and intraoperative variables, were comparable between groups. Maximum and average VAS pain scores over PODs 1-5 were similar across both treatment groups (p = 0.18 and p = 0.17, respectively). Patients in the OXY group consumed fewer pills over the 10-day period (median of 6.5 vs 12, p < 0.01). All other secondary outcomes were not different between the groups. Conclusion: NSAIDs provide comparable postoperative pain relief to opioids following PCNL, with minimal side effects, making them a viable option for patients without contraindications. Our study is the first level 1 evidence on this topic.