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NCT Number: NCT07618130

Opioid-Free Anesthesia and Pain Study in Cardiac Surgery Patients

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.

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Key information

Conditions

Posoperativ Pain Chronich Pain Opoid-free Managment Postoperativ Delirum

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Center of Serbia

Belgrade, Serbia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

elective cardiac surgery patients

Exclusion criteria

Emergecy cardiac surgery patients

Treatment and study plan

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.

Other names: Opioid-free, Anesthesia

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

Other names: sufentanil

Primary outcomes

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).

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

Time frame: 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 outcomes

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.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Dejan Markovic, MD, PhD, Associated Professor

CONTACT

[email protected]

+381668300903

Sponsors and collaborators

Lead sponsor

Clinical Centre of Serbia

Other

Registry information

Official study title

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

Acronym: OFPAINS-CS

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Jun 1, 2026
Registry last updated: Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.