Opioid-Free Anesthesia and Pain Study in Cardiac Surgery Patients

N/ANot Yet RecruitingNCT07618130

Clinical Centre of Serbia400 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

400

Conditions

Posoperativ Pain Chronich Pain

Interventions

Opioid Free AnaesthesiaPROCEDURE

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.

Opioid AnesthesiaPROCEDURE

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.