Quality of Recovery-15 After Opioid-free Versus Opioid-based General Anesthesia in Major Urological Surgery (QoR-OFA-URO)

This is a randomized, parallel-group, single-blind clinical trial evaluating postoperative quality of recovery assessed with the Quality of Recovery-15 questionnaire after opioid-free versus opioid-based general anesthesia in patients undergoing elective major urological surgery.

All consecutive adult patients scheduled for elective major urological surgery under general anesthesia will be screened for eligibility. Eligible surgical procedures include laparoscopic or robotic nephrectomy, laparoscopic or robotic prostatectomy, and laparoscopic or robotic cystectomy.

After providing written informed consent, participants will be randomly assigned to one of two treatment groups: opioid-free general anesthesia or opioid-based general anesthesia with intraoperative remifentanil.

In the opioid-free anesthesia group, anesthesia will be conducted without intraoperative opioids. The anesthetic protocol includes multimodal non-opioid analgesia using dexmedetomidine, ketamine, lidocaine, non-opioid analgesics, and procedure-specific regional analgesia. Sevoflurane will be used for maintenance of general anesthesia.

In the opioid-based anesthesia group, general anesthesia will include intraoperative remifentanil infusion. Sevoflurane will be used for maintenance of anesthesia. Standard non-opioid co-analgesics and procedure-specific regional analgesia will also be used according to the study protocol.

Regional analgesia will be selected according to the surgical procedure. Patients undergoing nephrectomy will receive bilateral erector spinae plane block. Patients undergoing prostatectomy will receive bilateral quadratus lumborum block. Patients undergoing cystectomy will receive continuous epidural analgesia with ropivacaine.

In the postoperative period, all patients will receive standardized analgesia. Postoperative analgesia will include oxycodone administered via patient-controlled analgesia or oral oxycodone/naloxone when appropriate, together with non-opioid co-analgesics such as paracetamol and metamizole. The PCA regimen will consist of oxycodone boluses of 2 mg, a 10-minute lockout interval, and no background infusion.

The main patient-reported outcome will be quality of postoperative recovery assessed with the Quality of Recovery-15 questionnaire. QoR-15 will be completed before surgery and on postoperative day 7. The postoperative day 7 QoR-15 total score and the change in QoR-15 score from baseline to postoperative day 7 will be compared between the opioid-free anesthesia group and the remifentanil-based anesthesia group.

Postoperative pain intensity will be assessed using the Numeric Rating Scale at 1, 2, 6, 12, and 24 hours after surgery. Total oxycodone consumption via PCA during the first 24 hours after surgery will be recorded. The numbers of demanded and delivered PCA boluses will be recorded to calculate the demanded-to-delivered bolus ratio. Postoperative nausea and vomiting will be assessed during the first 24 hours after surgery.

Laboratory outcomes will include serum creatinine and white blood cell count measured before surgery and on postoperative day 1.

Pre-specified subgroup analyses will be performed according to the type and surgical approach of the procedure: laparoscopic nephrectomy, robotic nephrectomy, laparoscopic prostatectomy, robotic prostatectomy, laparoscopic cystectomy, and robotic cystectomy. Treatment-by-subgroup interaction tests will be performed.