RecruitingNot Applicable

Opioid-free Anesthesia as an Alternative to General Anesthesia in Abdominal Surgery

Poland600 participantsStarted 2024-03-10

Plain-language summary

Opioid-free anesthesia (OFA) is a multimodal technique that eliminates intraoperative opioids by combining dexmedetomidine, ketamine, lidocaine, NSAIDs, and regional analgesia. Growing evidence suggests OFA reduces postoperative opioid consumption, opioid-related adverse effects, and may have favorable oncological implications in cancer surgery. This randomized controlled trial compares OFA with opioid-based anesthesia (remifentanil) in patients undergoing elective urological surgery: laparoscopic nephrectomy, robotic nephrectomy, laparoscopic prostatectomy, robotic prostatectomy, laparoscopic cystectomy, and robotic cystectomy. The PRIMARY OBJECTIVE is to compare the total postoperative oxycodone dose (mg) administered via patient-controlled analgesia (PCA) during the first 24 hours after surgery between the OFA and remifentanil groups. SECONDARY OBJECTIVES include: postoperative pain intensity (NRS) at 1, 2, 6, 12, and 24 hours; incidence of postoperative nausea and vomiting (PONV); change in serum creatinine from baseline to postoperative day 1; change in white blood cell (WBC) count from baseline to postoperative day 1; and the ratio of demanded to delivered PCA boluses. PRE-SPECIFIED SUBGROUP ANALYSES will compare outcomes by surgical procedure type: laparoscopic nephrectomy, robotic nephrectomy, laparoscopic prostatectomy, robotic prostatectomy, laparoscopic cystectomy, and robotic cystectomy. Subgroup-by-treatment interaction tests will be performed and reported as forest plots. Planned enrollment: approximately 600 patients (300 per arm). Follow-up: 24 hours postoperatively.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults aged 18-75 years scheduled for elective urological surgery under general anesthesia: laparoscopic or robotic nephrectomy, laparoscopic or robotic prostatectomy, or laparoscopic or robotic cystectomy. * Ability to operate a patient-controlled analgesia (PCA) pump postoperatively. * Ability to understand and use the Numeric Rating Scale (NRS) for pain assessment. * Written informed consent. Exclusion Criteria: * Patient's refusal to participate. * Inability to operate the PCA pump. * Inability to understand the NRS pain scale. * Known hypersensitivity to any of the study drugs (anesthetics, ketamine, dexmedetomidine, ropivacaine, oxycodone, metamizole, paracetamol, ibuprofen). * Second- or third-degree atrioventricular block, or symptomatic bradycardia. * Chronic opioid use. * Contraindication to the planned regional anesthesia technique (e.g. coagulopathy or therapeutic anticoagulation, infection at the puncture site).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Total postoperative oxycodone dose administered via PCA (mg)

Timeframe: 0-24 hours after surgery

Trial details

NCT IDNCT06380244

SponsorJagiellonian University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

View on ClinicalTrials.gov More Analgesics, Opioid trials