Quality of Recovery-15 After Opioid-free Versus Opioid-based General Anesthesia in Major Urological Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJagiellonian University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Remifentanil-based general anesthesia
DrugGeneral anesthesia with intraoperative remifentanil infusion, sevoflurane maintenance, non-opioid co-analgesics, procedure-specific regional analgesia, and standardized postoperative analgesia with oxycodone patient-controlled analgesia.
Opioid-free general anesthesia
DrugGeneral 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Opioid-based general anesthesia with remifentanilActive comparator 1 intervention
Group B: Opioid-free general anesthesiaExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
7 daysSecondary outcomes
1
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.
Time frame
1 day2
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.
Time frame
1 day3
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.
Time frame
1 daySponsors and contacts
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Source ClinicalTrials.gov