Opioid-Free Anesthesia and Pain Study in Cardiac Surgery Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Opioid Free Anaesthesia, Opioid Anesthesia.
- Who it may be relevant to
- Registry conditions: Posoperativ Pain, Chronich Pain, Postoperativ Delirum, Opoid-free Managment. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Serbia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
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.
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
Primary outcome measures
- Acute postoperativ pain [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 [Time frame: Chronic postoperative pain will be assessed 3 months after cardiac surgery. Patients will be contacted by phone]
Secondary outcome measures (1)
- Incidency of potsoperativ delirium [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.]
Eligibility criteria
Inclusion criteria
- elective cardiac surgery patients
Exclusion criteria
- Emergecy cardiac surgery patients
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Serbia · 1 center
- Clinical Center of Serbia — Belgrade
Identifiers
NCT: NCT07618130 · 95/20