Opioid-free Anesthesia as an Alternative to General Anesthesia in Abdominal Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJagiellonian University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
anesthesia without opioids
Other interventionOpioid free general anesthesia
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Opioid-based anesthesia (remifentanil)No intervention 0 interventions
Group B: Opioid-free anesthesia (OFA)Experimental treatment 1 intervention
Trial outcomes
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.
Time frame
0-24 hours after surgerySecondary outcomes
1
Postoperative pain (NRS)
Postoperative pain intensity as assessed by the Numeric Rating Scale (NRS) - NRS (0 = no pain, 10 = worst imaginable pain) at rest, compared between groups; score reported at each time point.
Time frame
1, 2, 6, 12, and 24 hours after surgeryOther outcomes
1
Postoperative nausea and vomiting (PONV)
Number of participants with postoperative nausea and/or vomiting (PONV) - Number (and proportion) of participants with any nausea and/or vomiting within 24 h after surgery (binary: yes/no), compared between groups.
Time frame
0-24 hours after surgery2
Postoperative renal function (serum creatinine)
Change in serum creatinine from baseline to postoperative day 1 (µmol/L) - Serum creatinine (µmol/L) at baseline (preoperative) and on POD1; change from baseline compared between groups.
Time frame
Baseline and postoperative day 13
Patient-controlled analgesia (PCA) demand/administered ratio
Ratio of demanded to delivered PCA boluses - Ratio of demanded to delivered PCA bolus attempts within 24 h after surgery, compared between groups.
Time frame
0-24 hours after surgery4
Change in white blood cell (WBC) count from baseline to postoperative day 1 (×10⁹/L)
White blood cell (WBC) count (×10⁹/L) measured preoperatively (baseline) and on postoperative day 1; change from baseline compared between the OFA and remifentanil groups.
Time frame
Baseline and postoperative day 1Sponsors and contacts
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Source ClinicalTrials.gov