Not Yet RecruitingNot Applicable

Opioid-Free Anesthesia and Pain Study in Cardiac Surgery Patients

Serbia400 participantsStarted 2026-07-01

Plain-language 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.

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * elective cardiac surgery patients Exclusion Criteria: * Emergecy cardiac surgery patients

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is testing opioid-free anesthesia during cardiac surgery — given my specific heart condition and overall health, is an opioid-free approach something my care team would consider safe and appropriate for me?
2Since this trial is not yet recruiting, do you know when it might open and whether there are similar opioid-free pain management studies already enrolling that I could look into in the meantime?
3The study is measuring both short-term pain right after surgery and chronic pain that persists long-term — what does current evidence say about whether opioid-free approaches can actually reduce the risk of developing long-lasting pain after cardiac surgery?
4One of the outcomes being tracked is postoperative delirium — is that something my doctors would be monitoring regardless of whether I join this trial, and how common is it after the type of cardiac surgery I'm facing?
5If I were to consider this trial, what would the practical differences be in how my pain is managed compared to the standard opioid-based approach your team would otherwise use for my recovery?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Acute postoperativ pain

Timeframe: 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

Timeframe: Chronic postoperative pain will be assessed 3 months after cardiac surgery. Patients will be contacted by phone

Trial details

NCT IDNCT07618130

SponsorClinical Centre of Serbia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-01

Contact for this trial

Dejan Markovic, MD, PhD, Associated Professor

+381668300903 drdejanmarkovic@gmail.com

View on ClinicalTrials.gov More Posoperativ Pain trials