Clinical trial

Serratus Anterior Plane Block for Minimal Invasive Cardiac Surgery: a Single Center Randomized-controlled Trial

Name

MMS.2021.042

Description

Analgesia in cardiac surgery is historically based on large doses of intravenous opiods. 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.

Trial arms

Trial start

2021-10-28

Estimated PCD

2023-02-13

Trial end

2023-02-13

Status

Completed

Phase

Early phase I

Treatment

Levobupivacaine

The 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.

Arms:

SAPB

Size

Primary endpoint

Analgesic effect of superficial SAPB in MICS

In the first 48 hours after surgery

Analgesic effect of superficial SAPB in MICS

In the first 48 hours after surgery

Eligibility criteria

Inclusion Criteria: - Patients scheduled for mitral valve surgery via port access, aortic valve replacement via right anterior thoracotomy and minimal invase 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. mexilatine, ketoconazol, 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Patient, intensivist, ICU nurses and data manager are blinded for the randomization.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 80, 'type': 'ACTUAL'}}

Updated at

2023-08-14

1 organization

1 product

4 indications

Organization

Algemeen Ziekenhuis Maria Middelares

Product

Levobupivacaine

Indication

Minimally Invasive Cardiac Surgery

Indication

Mitral Valve Surgery

Indication

Aortic Valve Replacement

Indication

MIDCAB