Quality of Recovery after opioid-free vs opioid-based general anesthesia in major urological surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, parallel-group, single-blind study compares two anesthesia approaches in adults aged 18 to 75 undergoing elective major urological surgery (nephrectomy, prostatectomy, or cystectomy, laparoscopic or robotic). Participants are assigned to opioid-free multimodal anesthesia or to opioid-based anesthesia with intraoperative remifentanil, with sevoflurane for maintenance and procedure-specific regional analgesia. Recovery is assessed postoperatively using the Quality of Recovery-15 questionnaire to determine if opioid-free anesthesia improves short-term recovery. Eligibility requires consent, ability to use pain scales and QoR-15, and suitability for postpartum analgesia devices as applicable. The trial is led by Jagiellonian University with a focus on comparing patient-centered recovery outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Intensive Interdisciplinary Care, Collegium Medicum, Jagiellonian University
  Krakow, Lesser Poland Voivodeship, Poland Recruiting

Study contacts

• Study coordinator: Tomasz Skladzien, MD PHD
• Email: tomasz.skladzien@uj.edu.pl
• Phone: 12 400 18 00

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.