Serratus Anterior Plane Block for Minimal Invasive Cardiac Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Replacement; Mitral Valve Surgery; Minimal Invasive Cardiac Surgery; Minimal Invasive Direct Coronary Artery Bypass
• Intervention / Treatment: Drug: Levobupivacaine

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium, 9000
    • AZ Maria Middelares

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Active Comparator: SAPB; 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.	Drug: Levobupivacaine; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesic effect of superficial SAPB in MICS	Numeric (pain) Rating Scale every 2 hours	In the first 48 hours after surgery
Analgesic effect of superficial SAPB in MICS	Total opioid consumption in the intensive care unit	In the first 48 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	PaCO2 every 4 hours, calculated by an arterial blood gas test	In the first 48 hours after surgery
Incidence of postoperative nausea and vomiting (PONV)	PONV every 2 hours	In the first 48 hours after surgery

Collaborators and Investigators

• Sponsor: Algemeen Ziekenhuis Maria Middelares
• Investigators: Study Director: Steffi Ryckaert, MSc, Algemeen Ziekenhuis Maria Middelares

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2021
• Primary Completion (Actual): February 13, 2023
• Study Completion (Actual): February 13, 2023

Study Registration Dates

• First Submitted: October 28, 2021
• First Submitted That Met QC Criteria: October 28, 2021
• First Posted (Actual): November 4, 2021

Study Record Updates

• Last Update Posted (Actual): August 7, 2024
• Last Update Submitted That Met QC Criteria: August 6, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Levobupivacaine
• Other Study ID Numbers: MMS.2021.042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No