Over-the-Counter Naproxen is an Effective Opioid Sparing Strategy for Post-Arthroscopy Pain
HONOLULU, HI—Naproxen significantly improved pain relief following arthroscopic surgery and reduced opioid utilization with no evidence of increased risk of adverse events, reported Evan Ekman, MD from Southern Orthopaedic Sports Medicine, Columbia, SC, at the American Pain Society's 31st Annual Scientific Meeting.
Naproxen, a non-selective non-steroidal anti-inflammatory drug (NSAID), reduces post-arthroscopy pain and inflammation, which may lead to decreased opioid use and may reduce the incidence of opioid-related adverse events. It has been argued that non-selective NSAIDs may not be as safe as selective NSAIDs, such as COX-2 selective inhibitors, when used peri-operatively because they impair platelet aggregation and could increase the risk of bleeding-related complications. Dr. Ekman and colleagues conducted a randomized, double-blind, placebo-controlled, parallel-group study on 156 patients aged 18–65 years requiring knee arthroscopy to evaluate the safety and efficacy of adding an over-the-counter (OTC) dose of naproxen to a multimodal pain management regimen.
Patients were randomized in a 1:1 ratio to receive either naproxen (n=73) or placebo (n=83) in combination with general and local anesthesia (20mL of bupivicaine 0.25% with epinephrine) and were allowed 1–2 tablets of hydrocodone bitartrate/acetaminophen 5mg/500mg every 4–6 hours as needed post-operatively. The primary endpoint was the total hydrocodone/acetaminophen use at 24 hours after knee arthroscopy. Secondary endpoints were fentanyl utilitization in the PACU, interval hydrocodone/acetaminophen use at 8, 12, 24, 48, and 72 hours, cumulative hydrocodone/APAP use at Days 2 and 3, pain (VAS) at rest and 90 degrees flexion, change in hemoglobin, adverse events, and the burden of bleeding.
Those in the naproxen group received naproxen 440mg the night before surgery, 440mg one hour before surgery, 220mg 6 hours after surgery, and then 220mg every 8 hours after the first post-operative dose for up to 2 doses on the first day only. For two days following the day of surgery, patients were instructed to take naproxen 220mg every 8 hours. Patients in the placebo group followed an identical schedule.
Immediately following surgery, an assessment of post-operative bleeding burden was conducted by the surgeon. Patients were instructed to complete a diary assessing pain (at rest and at 90 degrees flexion) at 1, 8, 12, 24, 48, and 72 hours post-op.
Patients in the naproxen group took statistically less hydrocodone/acetaminophen at 24 hours (P=0.0000013; P=0.018 at 8 hours, P=0.006 at 12 hours, P=<0.0001 at 48 hours, P=<0.00001 at 72 hours) and less fentanyl (P=0.051). Study results showed that patients receiving naproxen reported statistically less pain at all time points at rest (P=0.017 at 8 hours, P=0.059 at 12 hours, P<0.0001 at 24 hours, P=0.044 at 48 hours, P=0.038 at 72 hours) and less pain with knee flexion at 1, 12, 24, and 48 hours (P=0.024; P=0.013; P<0.0001, P<0.0001).
Dr. Ekman noted that there were no differences in bleeding-related, gastrointestinal, or other adverse events and stated that “peri-operative OTC naproxen is an effective, economical, opioid sparing strategy for arthroscopy. There is no evidence that OTC naproxen worsens bleeding related complications.”