Aortic Valve Replacement, Minimal Invasive Cardiac Surgery, Minimal Invasive Direct Coronary Artery Bypass, Mitral Valve Surgery
Conditions
Brief summary
Analgesia in cardiac surgery is historically based on large doses of intravenous opioids. However, this practice is rapidly changing due to Enhanced Recovery After Surgery (ERAS) protocols with proven benefits on morbidity and mortality. Also, the opioid crisis caused by opioid abuse, has changed anaesthesia practice to reduce the use of opioids after surgery. Therefore, perioperative multimodal pain management with regional anaesthesia in minimal invasive cardiac surgery (MICS) has gained a lot of interest. Serratus Anterior Plane Block (SAPB) is one example of the fascial plane chest wall blocks and aims at achieving complete sensory loss of the anterolateral hemithorax via blockade of the lateral cutaneous branches of the thoracic intercostal nerves (T2-T12). SAPB has already proved its efficacy in thoracic surgery as it reduced pain scores and opioid consumption compared to systemic analgesia in the first 12-24h after surgery. However only few studies investigated the effects of SAPB in minimal invasive cardiac surgery. Therefore the primary aim of this study is to investigate the analgesic effects of a superficial SAPB in Minimal Invasive Cardiac Surgery compared to a control group with standard intravenous opioid analgesia.
Detailed description
2 x 40 patients scheduled for mitral valve surgery via port access, aortic valve replacement via right anterior thoracotomy and minimal invasive direct coronary artery bypass (MIDCAB) surgery will be randomized in a control or SAPB group. Every patient will receive the standard anaesthetic treatment. At the end of the surgery, patients in the SAPB group will receive levobupivacaine 0.25 %, 2.5 mg/ml (dosage scheme: 1.25 mg/kg levobupivacaine 0.25%, with a maximum of 100 mg). Levobupivacaine will be given via ultrasound-guided infiltration, in plane, midaxillary, 4-5th rib, between the latissimus dorsi and serratus anterior muscle, at the end of the surgery. For both the SAPB group and the control group, the ICU nurse will repeatedly administer piritramide 2 mg intravenously, till numerical rating scale (NRS) are less than 4. Also paracetamol 1 g will be continued 4 times daily.
Interventions
DRUGLevobupivacaine
The Investigational Medical Product (IMP) is levobupivacaine 0,25%, 2,5 mg/ml, solution for injection. The dosage scheme is as following:1.25 mg/kg levobupivacaine 0,25%, with a maximum of 100 mg, As the standard anaesthetic management already contains levobupivacaine, a maximum dosage of 100 mg (40 ml) levobupivacaine will be administered during the SAPB. The IMP is given via ultrasound-guided infiltration, in plane, midaxillary, 4-5th rib, between the latissimus dorsi and serratus anterior muscle, at the end of surgery.
Sponsors
Algemeen Ziekenhuis Maria Middelares
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Masking description
Patient, intensivist, ICU nurses and data manager are blinded for the randomization.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Patients scheduled for mitral valve surgery via port access, aortic valve replacement via right anterior thoracotomy and minimal invasive direct coronary artery bypass
Exclusion criteria
* Patients who are pregnant or breastfeeding * BMI \>35 * Opioid abuse * Patients known with chronic pain * Patients known with allergy to local anaesthetics (in this case levobupivacaine) * Patients known with hypersensitivity to piritramide * Patients who receive medication that could possibly interact with levobupivacaine (sa. mexiletine, ketoconazole, theophylline) * Patients who simultaneously participate in another interventional clinical trial, unless the Principal Investigators of the clinical trials give consent by mutual agreement that the patient can participate in another interventional clinical trial * Soft tissue infection in the area of the procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic effect of superficial SAPB in MICS | In the first 48 hours after surgery | Numeric (pain) Rating Scale every 2 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative nausea and vomiting (PONV) | In the first 48 hours after surgery | PONV every 2 hours |
| Time to extubation in the intensive care unit | From arrival on the ICU until discharge on the ICU | — |
| ICU length of stay | From arrival on the ICU until discharge on the ICU | — |
| PaCO2 | In the first 48 hours after surgery | PaCO2 every 4 hours, calculated by an arterial blood gas test |
Countries
Belgium
Outcome results
None listed