Clinical trial NCT04854577: Postoperative Opioid-Sparing Effect of a Pecto-Intercostal Fascial Block and Opioid-Free Anesthesia.
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Opioid Free Anaesthesia
Opioid Anaesthesia
Keywords: Analgesics, Opioid
Anesthetics
Central Nervous System Depressants
Dexmedetomidine
Esketamine
Lidocaine
Ropivacaine
Pecto-Intercostal Fascial Plane Block
Physiological Effects of Drugs
Peripheral Nervous System Agents
Lead sponsor: Algemeen Stedelijk Ziekenhuis
Sponsor class: OTHER
First posted: 2021-04-22
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled, outcome assessor blinded study using two parallel study groups
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative morphine consumption
timeFrame: Day 2
Secondary outcomes:
measure: Time until extubation
timeFrame: Day 0
measure: Mean visual analogue score (VAS) pain score at rest
timeFrame: Day 2
measure: Mean visual analogue score (VAS) pain score whilst coughing
timeFrame: Day 2
measure: Incidence of postoperative nausea and vomiting
timeFrame: Day 2
measure: Incidence of postoperative delirium
timeFrame: Day 2
measure: Mean length of ICU stay
timeFrame: Day 2
Other outcomes:
Locations:
Study officials:
affiliation: Department of Anesthesiology, Pain and Intensive Care Medicine
name: Koen Lapage, M.D.
role: PRINCIPAL_INVESTIGATOR
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