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NOT YET RECRUITING
NCT07618130
NA

Opioid-Free Anesthesia and Pain Study in Cardiac Surgery Patients

Sponsor: Clinical Centre of Serbia

View on ClinicalTrials.gov

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.

Official title: Assessment od the Effects of Opioid-Free Anesthesia on Acute and Chronich Postsurgical Pain in Cardiac Surgery Patinets: A Prospective Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2026-07-01

Completion Date

2027-11-20

Last Updated

2026-06-01

Healthy Volunteers

No

Interventions

PROCEDURE

Opioid Free Anaesthesia

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.

PROCEDURE

Opioid 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

Locations (1)

Clinical Center of Serbia

Belgrade, Serbia