Patient Controlled Intravenous Analgesia with Oxycodone or Sufentanil After Hip Surgery: Study Protocol for a Multi-Centered, Randomized Controlled Trial.

Background: Patient-controlled intravenous analgesia (PCIA) after hip surgery should be focused on sufficient analgesia, recovery, and the risk of adverse effects. Sufentanil PCIA offers effective analgesia but with obvious side effects. Oxycodone, a semi-synthetic opioid, is reported to have good analgesic effects with fewer adverse effects compared to strong opioids. We hypothesize that in hip surgery, compared with sufentanil PCIA, oxycodone PCIA in an equipotent dose to sufentanil could achieve similar postoperative analgesia while reducing the incidence of adverse effects associated with strong opioids.

Methods: This multi-centered, randomized, controlled open-label clinical trial compares the efficacy of oxycodone and sufentanil for PCIA in hip surgery patients.

Results: A total of 570 subjects will be randomly allocated in a 1:1 ratio into either the oxycodone group or sufentanil group. The primary outcome is the resting numerical rating scale (NRS) pain scores at 2 h after surgery. The secondary outcomes include the incidence of postoperative nausea and vomiting (PONV), NRS pain scores on movement, complications, mobilization time, length of hospital stay, total in-hospital cost, etc.

Conclusions: This trial will provide evidence for the choice of PCIA in hip surgery by comparing the analgesic efficacy and side effects of oxycodone and sufentanil, serving as a foundation for postoperative pain management guidelines and recommendations. Trial Registration: Clinical Trials NCT03685188.