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

Not Applicable

• Conditions: Opioid Anaesthesia; Opioid Free Anaesthesia
• Interventions: Procedure: Opioid Free Anesthesia; Procedure: Traditional Anesthetic Regimen

• Registration Number: NCT04854577
• Lead Sponsor: Algemeen Stedelijk Ziekenhuis

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2021-04
• Study First Submitted: 2021-04-19
• Study First Submitted QC: 2021-04-19
• Last Update Submitted: 2021-04-19
• Study First Posted: 2021-04-22
• Last Update Posted: 2021-04-22
• Study Start: 2021-05
• Primary Completion: 2022-05
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group: "Opioid Free Anesthesia with a pecto-intercostal fascial plane block"	Opioid Free Anesthesia	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.
Control group: "Traditional Opioid-based Anesthetic Regimen"	Traditional Anesthetic Regimen	Patients who will receive a traditional opioid based anesthetic regimen. The administered dose of opioids is at the discretion of the attending anesthesiologist.

Primary Outcome Measures

Name	Time	Method
Postoperative morphine consumption	Day 2	The total amount of morphine used postoperatively in the intensive care unit until discharge.

Secondary Outcome Measures

Name	Time	Method
Incidence of postoperative delirium	Day 2	Incidence of postoperative delirium using the Confusion Assessment Method for ICU
Time until extubation	Day 0	The time between ICU-arrival and extubation
Mean visual analogue score (VAS) pain score at rest	Day 2	The mean VAS pain score at rest at 24 hours and 48 hours after extubation.
Mean visual analogue score (VAS) pain score whilst coughing	Day 2	The mean VAS pain score whilst coughing at 24 hours and 48 hours after extubation.
Incidence of postoperative nausea and vomiting	Day 2	Incidence of postoperative nausea and vomiting (PONV)
Mean length of ICU stay	Day 2	The mean length of ICU stay, reported in hours.