Serratus Anterior Plane Block for Minimal Invasive Cardiac Surgery

NCT05107453 | Completed Phase 4

• 1 other identifier: MMS.2021.042
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Minimal Invasive Cardiac Surgery; Mitral Valve Surgery; Aortic Valve Replacement; Minimal Invasive Direct Coronary Artery Bypass

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Incidence of postoperative nausea and vomiting (PONV)

  In the first 48 hours after surgery

• 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

Study Arms (2)

SAPB

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

Interventions

Levobupivacaine DRUG

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.

SAPB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients scheduled for mitral valve surgery via port access, aortic valve replacement via right anterior thoracotomy and minimal invasive direct coronary artery bypass

You may not qualify if:

• 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

Sponsors & Collaborators

• Algemeen Ziekenhuis Maria Middelares: lead

Study Sites (1)

AZ Maria Middelares

Ghent, 9000, Belgium

Location

MeSH Terms

Interventions

Levobupivacaine

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Steffi Ryckaert, MSc

  Algemeen Ziekenhuis Maria Middelares

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Patient, intensivist, ICU nurses and data manager are blinded for the randomization.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: November 4, 2021
• Study Start: October 28, 2021
• Primary Completion: February 13, 2023
• Study Completion: February 13, 2023
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)