An interventional study of Opioid Free Anaesthesia and Opioid Anesthesia in Posoperativ Pain, Chronich Pain and Postoperativ Delirum, sponsored by Clinical Centre of Serbia. Not yet recruiting at 1 site in Serbia. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by Clinical Centre of Serbia · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to compare the effect of opioid-free anesthesia on the intensity of acute and chronic postoperative pain in patients undergoing cardiac surgery. The study will also evaluate the safety of opioid-free anesthesia in this patient population.
The main questions it aims to answer are:
Additionally, the incidence of adverse events-including postoperative delirium (POD), hemodynamic instability, respiratory complications, constipation, and postoperative nausea and vomiting (PONV)-as well as overall treatment outcomes, will be evaluated.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 400 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Clinical Centre of Serbia is the lead sponsor of 24 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Patients in the opioid-free group will receive anesthesia without any opioids.
Procedure: Opioid Free Anaesthesia
In the opioid group, patients will receive conventional opioid-based anesthesia.
Procedure: Opioid Anesthesia
Anesthesia will consist of a multimodal combination of general non-opioid agents (propofol, dexmedetomidine, midazolam, sevoflurane, and esketamine) supplemented by regional anesthesia techniques, including the erector spinae plane block (ESPB), serratus anterior plane block, and parasternal block.
Also known as: Opioid-free, Anesthesia
This will include intraoperative opioids (e.g., fentanyl or sufentanil) in combination with general anesthetic agents such as propofol, sevoflurane, and midazolam, supplemented by additional analgesics as required. Regional anesthesia techniques (e.g., erector spinae plane block, serratus anterior plane block, or parasternal block) may also be performed at the discretion of the attending anesthesiologist
Also known as: sufentanil
Acute postoperativ pain
Postoperative pain will be assessed using the Numeric Rating Pain Scale (NRPS/NRS 0-10) after cardiac surgery
Time frame: Assessments will be performed upon extubation (T0) and then every 12 hours for the first 48 postoperative hours (at 12, 24, 36, and 48 hours).
Chronich postoperative pain
Assessed using NRS (0-10) for average and worst pain intensity. Analgesic medication use (type and dose) related to the surgery will also be recorded at this time point.
Time frame: Chronic postoperative pain will be assessed 3 months after cardiac surgery. Patients will be contacted by phone
Incidency of potsoperativ delirium
The occurrence of postoperative delirium will be monitored using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). The incidence of delirium is defined as at least one positive C
Time frame: Screening will begin after extubation and will be performed twice daily (once in the morning and once in the evening) for the first 5 postoperative days or until discharge from the hospital.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jul 2026; primary completion for Jul 2027, 12 months later.
Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's planned 12 months is above that.
Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Clinical Centre of Serbia