Pregabalin naproxencarbil in acute post-bunionectomy pain: a randomized clinical trial.

Introduction: Practice guidelines recommend multimodal approaches for better management of acute pain including the administration of two or more drugs that act by different analgesic mechanisms. Objective: The study aimed to assess pregabalin naproxencarbil (PNC), a new chemical entity targeting both nociceptive and neuropathic pain pathways, for the management of acute pain. Methods: This randomized, double-blind, placebo-controlled trial enrolled 450 participants scheduled for first metatarsal bunionectomy. Participants were randomized (1:1:1) to receive either 1250 mg or 750 mg of PNC or placebo. Study drug was administered 1 hour before surgery and thereafter every 12 hours for 72 hours. Participants reported numeric pain rating scale to calculate summed pain intensity (SPI). Rescue pain medication use and safety were monitored. Results: The least-squares mean (LSM) (SE) of SPI over 48 hours (SPI48) for the 1250 mg PNC group vs placebo as the primary efficacy end point was 132.6 (8.0) vs 286.0 (8.2) ( Conclusion: Pregabalin naproxencarbil dose-dependently reduced acute postoperative pain with acceptable safety profiles. Trial registration: ClinicalTrials.gov Identifier: NCT06017999.