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

NCT06380244 | Recruiting DMC

• 1 other identifier: 1072.6120.136.2023
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Analgesics, Opioid; Anesthesia, Endotracheal; Anesthesia, General

Outcome Measures

Primary Outcomes (1)

• Total postoperative oxycodone dose administered via PCA (mg)

  Total postoperative oxycodone dose administered via PCA (mg) - Cumulative dose of oxycodone (mg) self-administered via PCA pump during the first 24 hours after surgery, compared between the OFA and remifentanil groups.

  0-24 hours after surgery

Secondary Outcomes (1)

• Postoperative pain (NRS)

  1, 2, 6, 12, and 24 hours after surgery

Other Outcomes (4)

• Postoperative nausea and vomiting (PONV)

  0-24 hours after surgery

• Postoperative renal function (serum creatinine)

  Baseline and postoperative day 1

• Patient-controlled analgesia (PCA) demand/administered ratio

  0-24 hours after surgery

Study Arms (2)

Opioid-based anesthesia (remifentanil)

NO INTERVENTION

Opioid-based general anesthesia. Premedication includes dexamethasone, paracetamol, metamizole, magnesium sulfate, and ibuprofen. Induction with propofol and rocuronium under TOF monitoring. Maintenance with sevoflurane titrated to MAC; intraoperative analgesia provided by remifentanil infusion (total intraoperative dose recorded). Regional analgesia by procedure: bilateral ESP block (nephrectomy), bilateral QL block (prostatectomy), and continuous epidural ropivacaine infusion (cystectomy). Postoperative analgesia: oxycodone PCA (2 mg bolus, 10-min lockout, no background infusion) with paracetamol and metamizole.

Opioid-free anesthesia (OFA)

EXPERIMENTAL

Opioid-free general anesthesia. Premedication includes dexamethasone, paracetamol, metamizole, magnesium sulfate, ibuprofen, and dexmedetomidine (OFA group only). Induction with propofol, ketamine (OFA group only), and rocuronium under TOF monitoring. Maintenance with sevoflurane titrated to MAC; intraoperative analgesia provided by a continuous dexmedetomidine/ketamine infusion with rescue boluses for tachycardia or hypertension. Regional analgesia by procedure: bilateral ESP block (nephrectomy), bilateral QL block (prostatectomy), and continuous epidural ropivacaine infusion (cystectomy). Postoperative analgesia: oxycodone PCA (2 mg bolus, 10-min lockout, no background infusion) with paracetamol and metamizole.

Other: anesthesia without opioids

Interventions

anesthesia without opioids OTHER

Opioid free general anesthesia

Opioid-free anesthesia (OFA)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

Jagiellonian University

Krakow, Lesser Poland Voivodeship, 31501, Poland

RECRUITING

MeSH Terms

Interventions

Anesthesia; Analgesics, Opioid

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PHD

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 23, 2024
• Study Start: March 10, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be available in 2026 for 1 year

Locations

PL (1)