Opioid-Free Anesthesia and Pain Study in Cardiac Surgery Patients (OFPAINS-CS)

Clinical Centre of Serbia

Status: Begins enrollment this month

Conditions: Postoperativ Delirum; Chronich Pain; Posoperativ Pain; Opoid-free Managment

Treatments: Procedure: Opioid Anesthesia; Procedure: Opioid Free Anaesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT07618130

95/20

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• elective cardiac surgery patients

Exclusion criteria

• Emergecy cardiac surgery patients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Opioid-Free Anesthesia Groupe

Experimental group

Description:

Patients in the opioid-free group will receive anesthesia without any opioids.

Treatment:

Procedure: Opioid Free Anaesthesia

Opioid anesthesia groupe

Active Comparator group

Description:

In the opioid group, patients will receive conventional opioid-based anesthesia.

Treatment:

Procedure: Opioid Anesthesia