Opioid Anaesthesia, Opioid Free Anaesthesia
Conditions
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
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.
Interventions
PROCEDUREOpioid Free Anesthesia
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.
PROCEDURETraditional Anesthetic Regimen
Patients will be administered a traditional anesthetic regimen which is based on sufentanil dosage. The dosage is at the discretion of the attending anesthesiologist.
Sponsors
Algemeen Stedelijk Ziekenhuis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The patient will not be made aware of what has been administered. The outcome assessor will be blinded for the group allocation of patients. The investigator, as one of the care providers, nor the care providers can be blinded for the administered anesthetic regimen. The opioid free anesthetic regimen will be conducted by the same anesthesiologist.
Intervention model description
A randomized controlled, outcome assessor blinded study using two parallel study groups
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative morphine consumption | Day 2 | The total amount of morphine used postoperatively in the intensive care unit until discharge. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Time until extubation | Day 0 | The time between ICU-arrival and extubation |
| Incidence of postoperative delirium | Day 2 | Incidence of postoperative delirium using the Confusion Assessment Method for ICU |
| Mean length of ICU stay | Day 2 | The mean length of ICU stay, reported in hours. |
| Incidence of postoperative nausea and vomiting | Day 2 | Incidence of postoperative nausea and vomiting (PONV) |
Contacts
Primary ContactKoen Lapage, M.D.
Outcome results
None listed