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

Study Overview
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Brief Summary
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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
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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: Intervention group: Opioid-free anesthetic regimen with a pre-incisional pecto-intercostal fascial plane block (PIFB); 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.

Official Title
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The Postoperative Opioid-Sparing Effect of an Intraoperative Pecto-Intercostal Fascial Block and Opioid-Free Anesthesia in Cardiac Surgery Patients: a Prospective Randomized Controlled Trial

Conditions
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Opioid Free Anaesthesia, Opioid Anaesthesia

Intervention / Treatment
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* Procedure: Opioid Free Anesthesia
* Procedure: Traditional Anesthetic Regimen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized controlled, outcome assessor blinded study using two parallel study groups
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group: Opioid Free Anesthesia with a pecto-intercostal fascial plane block<br>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. | Procedure: Opioid Free Anesthesia<br>* Patients will be administered a combination of a pre-incisional pecto-intercostal fascial plane block and a standardized opioid free anesthetic regimen consisting of dexmedetomidine, esketamine and lidocaine.<br>|
| Active Comparator: Control group: Traditional Opioid-based Anesthetic Regimen<br>Patients who will receive a traditional opioid based anesthetic regimen. The administered dose of opioids is at the discretion of the attending anesthesiologist. | Procedure: Traditional Anesthetic Regimen<br>* Patients will be administered a traditional anesthetic regimen which is based on sufentanil dosage. The dosage is at the discretion of the attending anesthesiologist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative morphine consumption | The total amount of morphine used postoperatively in the intensive care unit until discharge. | Day 2 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Analgesics, Opioid, Anesthetics, Central Nervous System Depressants, Dexmedetomidine, Esketamine, Lidocaine, Ropivacaine, Pecto-Intercostal Fascial Plane Block, Physiological Effects of Drugs, Peripheral Nervous System Agents