Background
Intravenous patient-controlled analgesia (PCA) after hip surgery should be focused on the balance of sufficient analgesia and the risk of associated adverse reactions. Sufentanil has high analgesic efficacy as a common used drug for PCA while with obvious side effects. Oxycodone is a semi-synthetic opioid which has been reported to have good analgesic effect and lower incidence of adverse reactions related to long-acting opioid. We hypothesize that in hip surgery, compared with sufentanil PCA, the equipotency dose of oxycodone PCA could achieve the same postoperative analgesic efficacy and may also reduce the incidence of adverse reactions associated with long-acting opioids.
Methods/Design
This trial is a prospective, randomized, controlled clinical trial comparing the safety and efficacy of oxycodone and sufentanil for postoperative patient-controlled analgesia in patients undergoing hip surgery. A total of 570 subjects undergoing hip surgery will be randomly allocated to either sufentanil PCA group or oxycodone PCA group. The primary outcome is the resting numerical rating scales (NRS) pain scores at 30 min, 2 h, 6 h, 24 h, 48 h, and 72h after surgery. The secondary outcomes include postoperative NRS pain scores on movement, in-hospital complications, range of motion of hip joints, mobilization time, length of hospital stay, total in-hospital cost, and readmission rate by 30 days after discharge from the hospital.
Discussion
This trial is designed to compare the safety and efficacy of oxycodone and sufentanil PCA in patients undergoing hip surgery, in order to find an optimal postoperative analgesic regime with fewer adverse reactions and promoting patients’ rehabilitation. The results will provide evidence for anesthetic choice in clinical practice.