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

Uality of Recovery-15 After Opioid-free Versus Opioid-based General Anesthesia in Patients Undergoing Elective Major Urological Surgery: A Randomized Controlled Trial

This randomized controlled trial evaluates postoperative quality of recovery assessed with the Quality of Recovery-15 questionnaire in adult patients undergoing elective major urological surgery under opioid-free versus opioid-based general anesthesia.

Opioid-free anesthesia is a multimodal anesthetic technique that avoids intraoperative opioids by combining non-opioid analgesic and sympatholytic agents such as dexmedetomidine, ketamine, lidocaine, non-steroidal anti-inflammatory drugs, and regional analgesia. Opioid-based general anesthesia in this trial includes intraoperative remifentanil infusion.

Participants will undergo elective urological surgery, including laparoscopic nephrectomy, robotic nephrectomy, laparoscopic prostatectomy, robotic prostatectomy, laparoscopic cystectomy, or robotic cystectomy.

The primary objective is to compare patient-reported quality of recovery between the opioid-free anesthesia group and the remifentanil-based anesthesia group using the Quality of Recovery-15 questionnaire. QoR-15 will be assessed before surgery and on postoperative day 7.

Secondary objectives include total postoperative oxycodone dose administered via patient-controlled analgesia during the first 24 hours after surgery, postoperative pain intensity measured using the Numeric Rating Scale at 1, 2, 6, 12, and 24 hours after surgery, incidence of postoperative nausea and vomiting, change in serum creatinine from baseline to postoperative day 1, change in white blood cell count from baseline to postoperative day 1, and the ratio of demanded to delivered PCA boluses.

Pre-specified subgroup analyses will compare outcomes according to surgical procedure type: laparoscopic nephrectomy, robotic nephrectomy, laparoscopic prostatectomy, robotic prostatectomy, laparoscopic cystectomy, and robotic cystectomy. Subgroup-by-treatment interaction tests will be performed.

Planned enrollment is approximately 600 patients, with 300 patients per treatment arm. The primary patient-reported recovery endpoint will be assessed on postoperative day 7, while analgesic, pain, and early postoperative safety outcomes will be assessed during the first 24 hours after surgery.

Study Overview

• Status: Not yet recruiting
• Conditions: Anesthesia, General; Analgesics, Opioid; Postoperative Recovery; Urologic Surgical Procedure
• Intervention / Treatment: Drug: Remifentanil-based general anesthesia; Drug: Opioid-free general anesthesia

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tomasz Skladzien, MD PHD; Phone Number: +48 12 400 18 00; Email: tomasz.skladzien@uj.edu.pl

Study Locations

• Poland
  • Lesser Poland Voivodeship
    • Cracow, Lesser Poland Voivodeship, Poland, 30-688
      • Department of Intensive Interdisciplinary Care, Collegium Medicum, Jagiellonian University
      • Contact: Tomasz Skladzien, phd md; Phone Number: +48 12 400 1800; Email: tomasz.skladzien@uj.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 18 to 75 years.
• Scheduled for elective major urological surgery under general anesthesia, including laparoscopic or robotic nephrectomy, laparoscopic or robotic prostatectomy, or laparoscopic or robotic cystectomy.
• Ability to operate a patient-controlled analgesia pump postoperatively.
• Ability to understand and use the Numeric Rating Scale for pain assessment.
• Ability to understand and complete the Quality of Recovery-15 questionnaire.
• Written informed consent.

Exclusion Criteria:

• Patient refusal to participate.
• Inability to operate the patient-controlled analgesia pump.
• Inability to understand the Numeric Rating Scale for pain assessment.
• Inability to understand or complete the Quality of Recovery-15 questionnaire.
• Known hypersensitivity to any of the study drugs, including anesthetics, ketamine, dexmedetomidine, lidocaine, ropivacaine, oxycodone, metamizole, paracetamol, or ibuprofen.
• Second- or third-degree atrioventricular block.
• Symptomatic bradycardia.
• Chronic opioid use.
• Contraindication to the planned regional anesthesia technique, including coagulopathy, therapeutic anticoagulation, or infection at the puncture site.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Opioid-based general anesthesia with remifentanil; Participants assigned to this arm will receive opioid-based general anesthesia with intraoperative remifentanil infusion. Premedication includes dexamethasone, paracetamol, metamizole, magnesium sulfate, and ibuprofen. Anesthesia induction will be performed with propofol and rocuronium under train-of-four monitoring. Maintenance of anesthesia will be provided with sevoflurane titrated to minimum alveolar concentration. Intraoperative analgesia will be provided by remifentanil infusion, and the total intraoperative remifentanil dose will be recorded. Procedure-specific regional analgesia will include bilateral erector spinae plane block for nephrectomy, and continuous epidural ropivacaine infusion for cystectomy. Postoperative analgesia will include oxycodone patient-controlled analgesia with 2 mg boluses, a 10-minute lockout interval, and no background infusion, together with paracetamol and metamizole.	Drug: Remifentanil-based general anesthesia; General anesthesia with intraoperative remifentanil infusion, sevoflurane maintenance, non-opioid co-analgesics, procedure-specific regional analgesia, and standardized postoperative analgesia with oxycodone patient-controlled analgesia.
Experimental: Opioid-free general anesthesia; Participants assigned to this arm will receive opioid-free general anesthesia. Premedication includes dexamethasone, paracetamol, metamizole, magnesium sulfate, ibuprofen, and dexmedetomidine. Anesthesia induction will be performed with propofol, ketamine, and rocuronium under train-of-four monitoring. Maintenance of anesthesia will be provided with sevoflurane titrated to minimum alveolar concentration. Intraoperative analgesia and sympatholysis will be provided by continuous dexmedetomidine, ketamine, and lidocaine infusion, with rescue treatment for tachycardia or hypertension according to the study protocol. Procedure-specific regional analgesia will include bilateral erector spinae plane block for nephrectomy, bilateral quadratus lumborum block for prostatectomy, and continuous epidural ropivacaine infusion for cystectomy. Postoperative analgesia will include oxycodone patient-controlled analgesia with 2 mg boluses, a 10-minute lockout interval, and no background infusion, to	Drug: Opioid-free general anesthesia; General anesthesia without intraoperative opioids using dexmedetomidine, ketamine, lidocaine, sevoflurane, non-opioid co-analgesics, procedure-specific regional analgesia, and standardized postoperative analgesia with oxycodone patient-controlled analgesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Recovery-15 score on postoperative day 7	Patient-reported quality of postoperative recovery assessed using the Quality of Recovery-15 questionnaire on postoperative day 7. The total QoR-15 score will be compared between the opioid-free general anesthesia group and the remifentanil-based general anesthesia group.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total postoperative oxycodone dose administered via PCA	Total postoperative oxycodone dose administered via patient-controlled analgesia, expressed in milligrams. The cumulative dose of oxycodone self-administered via PCA pump during the first 24 hours after surgery will be compared between the opioid-free general anesthesia group and the remifentanil-based general anesthesia group.	1 day
Postoperative pain intensity assessed using the Numeric Rating Scale	Postoperative pain intensity at rest assessed using the Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Scores will be recorded and compared between groups at each predefined postoperative time point.	1 day
Postoperative nausea and vomiting	Number and proportion of participants with any postoperative nausea and/or vomiting within the first 24 hours after surgery. The incidence of postoperative nausea and vomiting will be compared between the opioid-free general anesthesia group and the remifentanil-based general anesthesia group.	1 day

Collaborators and Investigators

• Sponsor: Jagiellonian University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: June 18, 2026
• First Submitted That Met QC Criteria: June 18, 2026
• First Posted (Actual): June 24, 2026

Study Record Updates

• Last Update Posted (Actual): June 24, 2026
• Last Update Submitted That Met QC Criteria: June 18, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Remifentanil; Urological surgery; QoR-15; Quality of Recovery-15; Opioid-free anesthesia
• Other Study ID Numbers: 1072.6120.136.2023 QoR-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data will be shared, including demographic data, type of surgery, treatment allocation, Quality of Recovery-15 questionnaire scores, postoperative pain scores, opioid consumption, patient-controlled analgesia use data, postoperative nausea and vomiting
• IPD Sharing Time Frame: Data will become available after completion of the study and publication of the primary results, anticipated in 2026, and will remain available for 1 year.
• IPD Sharing Access Criteria: Data will be made available to qualified researchers upon reasonable request for scientific purposes, after approval by the principal investigator and, where required, by the relevant ethics committee. Data will be shared in de-identified form.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No