Serratus Anterior Plane Block for Minimal Invasive Cardiac Surgery

Aortic Valve Replacement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05107453
• Other study ID #: MMS.2021.042
• Status: Completed
• Phase: Phase 4
• Start date: October 28, 2021
• Est. completion date: February 13, 2023

Study information

• Verified date: August 2023
• Source: Algemeen Ziekenhuis Maria Middelares
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

2 x 40 patients scheduled for mitral valve surgery via port access, aortic valve replacement via right anterior thoracotomy and minimal invasice 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 continoued 4 times daily.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 13, 2023
• Est. primary completion date: February 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Replacement
• Mitral Valve Surgery

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Belgium	AZ Maria Middelares	Gent

Sponsors (1)

Lead Sponsor	Collaborator
Algemeen Ziekenhuis Maria Middelares

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analgesic effect of superficial SAPB in MICS	Numeric (pain) Rating Scale every 2 hours	In the first 48 hours after surgery
Primary	Analgesic effect of superficial SAPB in MICS	Total opioid consumption in the intensive care unit	In the first 48 hours after surgery
Secondary	Incidence of postoperative nausea and vomiting	PONV every 2 hours	In the first 48 hours after surgery
Secondary	Time to extubation in the intensive care unit		From arrival on the ICU until discharge on the ICU
Secondary	ICU length of stay		From arrival on the ICU until discharge on the ICU
Secondary	PaCO2	PaCO2 every 4 hours, calculated by an arterial blood gas test	In the first 48 hours after surgery