Chronich Pain, Opoid-free Managment, Posoperativ Pain, Postoperativ Delirum
Conditions
Keywords
OPIOPID-FREE, ANESTHESIA, CARDIAC SURGERY, ACUT PAIN, CHRONICH PAIN, POD
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.
Interventions
PROCEDUREOpioid 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.
PROCEDUREOpioid 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
Sponsors
Clinical Centre of Serbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* elective cardiac surgery patients
Exclusion criteria
* Emergecy cardiac surgery patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute postoperativ pain | 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). | Postoperative pain will be assessed using the Numeric Rating Pain Scale (NRPS/NRS 0-10) after cardiac surgery |
| Chronich postoperative pain | Chronic postoperative pain will be assessed 3 months after cardiac surgery. Patients will be contacted by phone | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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 |
Countries
Serbia
Contacts
CONTACTDejan Markovic, MD, PhD, Associated Professor
Outcome results
None listed