Postoperative Opioid-Sparing Effect of a Pecto-Intercostal Fascial Block and Opioid-Free Anesthesia.

Algemeen Stedelijk Ziekenhuis

Status: Unknown

Conditions: Opioid Anaesthesia; Opioid Free Anaesthesia

Treatments: Procedure: Opioid Free Anesthesia; Procedure: Traditional Anesthetic Regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT04854577

2021-002164-43 (EudraCT Number)

APIC2021150303

Details and patient eligibility

About

The present study aims to assess the difference in postoperative opioid consumption between patients who intraoperatively receive a pecto-intercostal facial block combined with opioid-free anesthesia versus a traditional opioid-based regimen for cardiac surgery. The literature on opioid-free anesthesia for cardiac surgery is minimal and solely consists of case reports and retrospective studies. Nevertheless, these reports show the feasibility of opioid-free anesthesia. The purpose of this study is to assess the opioid-sparing effect and efficacy of combining an opioid-free anesthetic regimen with a pecto-intercostal fascial plane block (PIFB) in patients undergoing cardiac surgery.

We hypothesize that opioid-free cardiac anesthesia with an intraoperative PIFB significantly reduces postoperative opioid consumption in comparison to a high-dose opioid intraoperative regimen.

Full description

Patients, aged 18 years or older, scheduled for coronary artery bypass graft surgery (CABG) with a complete midline sternotomy as surgical approach will be recruited for this study.

Patients planned for this particular surgical procedure will be recruited and allocated to one of 2 groups:

1. "Intervention" group: Opioid-free anesthetic regimen with a pre-incisional pecto-intercostal fascial plane block (PIFB);
2. "Control" group: traditional opiate-based anesthetic regimen in which the dosage of the opioids is at the discretion of the attending anesthesiologist.

Based on our power analysis, each group will consist of 64 patients.

Enrollment: 64 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18 years or older
• Patients scheduled for coronary artery bypass graft surgery (CABG), which includes a complete midline sternotomy.

Exclusion criteria

• CABG surgery which did not include a complete midline sternotomy
• Valve surgery
• Aortic surgery
• Emergency cardiac surgery
• Known allergy for ropivacaine
• Participation in another clinical trial
• Known drug abuse
• Preoperative cognitive dysfunction
• Preoperative pain therapy with opioids or anticonvulsants 14 days before surgery
• Patients unable to use Patient Controlled Analgesia (PCA)
• Need of reintubation after initial extubation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups

Intervention group: "Opioid Free Anesthesia with a pecto-intercostal fascial plane block"

Experimental group

Description:

Patients to whom a standardized opioid free anesthesia consisting of esketamine, lidocaine and dexmedetomidine will be administered with a pre-incisional pecto-intercostal fascial plane block.

Treatment:

Procedure: Opioid Free Anesthesia

Control group: "Traditional Opioid-based Anesthetic Regimen"

Active Comparator group

Description:

Patients who will receive a traditional opioid based anesthetic regimen. The administered dose of opioids is at the discretion of the attending anesthesiologist.

Treatment:

Procedure: Traditional Anesthetic Regimen