Serratus Anterior Plane Block for Minimal Invasive Cardiac Surgery

Phase 4

Completed

• Conditions: Minimal Invasive Cardiac Surgery; Aortic Valve Replacement; Mitral Valve Surgery; Minimal Invasive Direct Coronary Artery Bypass
• Interventions: Drug: Levobupivacaine

• Registration Number: NCT05107453
• Lead Sponsor: Algemeen Ziekenhuis Maria Middelares

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.

Study Timeline

• Study Start: 2021-10-28
• Study First Submitted: 2021-10-28
• Study First Submitted QC: 2021-10-28
• Study First Posted: 2021-11-04
• Primary Completion: 2023-02-13
• Study Completion: 2023-02-13
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SAPB	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.

Primary Outcome Measures

Name	Time	Method
Analgesic effect of superficial SAPB in MICS	In the first 48 hours after surgery	Total opioid consumption in the intensive care unit

Secondary Outcome Measures

Name	Time	Method
Incidence of postoperative nausea and vomiting (PONV)	In the first 48 hours after surgery	PONV every 2 hours
ICU length of stay	From arrival on the ICU until discharge on the ICU
Time to extubation in the intensive care unit	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

Trial Locations

Locations (1)

AZ Maria Middelares; 🇧🇪 Gent, Belgium