Clinical Trial

Opioid-Free Anesthesia and Pain Study in Cardiac Surgery Patients

Study acronym: OFPAINS-CS
Not Yet Recruiting
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Summary
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: * Is opioid-free anesthesia effective in reducing the intensity of acute and chronic postoperative pain in cardiac surgery patients? * Is this anesthetic technique safe in this patient population? Patients will be randomized before surgery into two groups. In the first group, anesthesia will be performed with opioids, while in the second group, anesthesia will be performed without opioids. Researchers will measure acute postoperative pain during the first 48 hours using the Numeric Rating Pain Scale (NRPS). Chronic postoperative pain will be assessed after 3 months via a telephone interview. 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.
Trial Details
NCT Number NCT07618130
Lead Sponsor Clinical Centre of Serbia
Conditions Posoperativ Pain, Chronich Pain, Postoperativ Delirum, Opoid-free Managment
Enrollment 400 participants
Start Date 2026-07-01
Primary Completion 2027-07-01 (estimated)
Study Completion 2027-11-20 (estimated)
Updated on ClinicalTrials.gov 2026-06-01