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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 64
- Primary Endpoint
- Postoperative morphine consumption
Study Overview
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:
- "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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, 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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Postoperative morphine consumption
Time Frame: Day 2
The total amount of morphine used postoperatively in the intensive care unit until discharge.
Secondary Outcomes
- Mean length of ICU stay(Day 2)
- Time until extubation(Day 0)
- Mean visual analogue score (VAS) pain score at rest(Day 2)
- Mean visual analogue score (VAS) pain score whilst coughing(Day 2)
- Incidence of postoperative nausea and vomiting(Day 2)
- Incidence of postoperative delirium(Day 2)
Investigators
Koen Lapage, M.D.
Consultant Anesthesiology
Algemeen Stedelijk Ziekenhuis