Opioid-Free Anesthesia and Pain Study in Cardiac Surgery Patients

NCT07618130 | Not Yet Recruiting

• 1 other identifier: 95/20
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Posoperativ Pain; Chronich Pain; Postoperativ Delirum; Opoid-free Managment

Keywords

OPIOPID-FREE, ANESTHESIA, CARDIAC SURGERY, ACUT PAIN, CHRONICH PAIN, POD

Outcome Measures

Primary Outcomes (2)

• Acute postoperativ pain

  Postoperative pain will be assessed using the Numeric Rating Pain Scale (NRPS/NRS 0-10) after cardiac surgery

  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.

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

Secondary Outcomes (1)

• Incidency of potsoperativ delirium

  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.

Study Arms (2)

Opioid-Free Anesthesia Groupe

EXPERIMENTAL

Patients in the opioid-free group will receive anesthesia without any opioids.

Procedure: Opioid Free Anaesthesia

Opioid anesthesia groupe

ACTIVE COMPARATOR

In the opioid group, patients will receive conventional opioid-based anesthesia.

Procedure: Opioid Anesthesia

Interventions

Opioid Free Anaesthesia PROCEDURE

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

Opioid-Free Anesthesia Groupe

Opioid Anesthesia PROCEDURE

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

Opioid anesthesia groupe

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elective cardiac surgery patients

You may not qualify if:

• Emergecy cardiac surgery patients

Sponsors & Collaborators

• Clinical Centre of Serbia: lead

Study Sites (1)

Clinical Center of Serbia

Belgrade, Serbia

Location

MeSH Terms

Interventions

Anesthesia; Sufentanil

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Dejan Markovic, MD, PhD, Associated Professor

CONTACT

+381668300903; drdejanmarkovic@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Associate Professor

Study Record Dates

• First Submitted: May 24, 2026
• First Posted: June 1, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): November 20, 2027
• Last Updated: June 1, 2026

Record last verified: 2026-05

Locations

SE (1)