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

Recruiting now · Not applicable

Conditions studied: Analgesics, Opioid, Anesthesia, Endotracheal, Anesthesia, General

In brief

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.

Key facts

Study ID: NCT06380244
Run by: Jagiellonian University
People needed: 600
Starts: 2024-03-10
Expected to finish: 2026-12-31
Last updated by the study team: 2026-06-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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).

Where it is running

Jagiellonian University — Krakow, Lesser Poland Voivodeship, Poland (enrolling)

Full record on ClinicalTrials.gov

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