Serratus Anterior Plane Block for Minimal Invasive Cardiac Surgery

Status Completed

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05107453
Study type	Interventional
Source	Algemeen Ziekenhuis Maria Middelares
Contact
Status	Completed
Phase	Phase 4
Start date	October 28, 2021
Completion date	February 13, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT00774293` - Homoeopathic Association in Aortic Valve Surgery	Phase 4
Completed	`NCT01651780` - Open-label, Randomized Trial in Patients Undergoing TAVR to Determine Safety & Efficacy of Bivalirudin vs UFH	Phase 3
Completed	`NCT01187329` - The Effect of the Hyperinsulinemic Normoglycemic Clamp on Myocardial Function and Utilization of Glucose	N/A
Recruiting	`NCT05295628` - Evaluation of Safety and Effectiveness of the EMBLOK EPS During TAVR	N/A
Terminated	`NCT03680040` - RESILIENCE Trial: Evaluation of the Durability of Aortic Bioprostheses/Valves With RESILIA Tissue in Subjects Under 65
Recruiting	`NCT05539937` - Prospective Evaluation of the Quality of Life of Elderly Patients Undergoing Transfemoral Percutanous Aortic Valve Replacement (TAVI) for the Treatment of Severe Aortic Stenosis.
Recruiting	`NCT01522352` - Comparison Between Three Types of Stented Pericardial Aortic Valves	N/A
Completed	`NCT01554709` - Safety and Performance Study of the CardioGard Cannula	Phase 2/Phase 3
Suspended	`NCT04902053` - INSPIRIS RESILIA Aortic Valve, Valve-in-Valve Surveillance Study
Completed	`NCT01404975` - TAVI Protocol - Paravertebral Block Study	N/A
Recruiting	`NCT03889288` - Innovative Device for Pain Management by Millimeter Band Radiation: Electronic-Pain Killer	N/A
Active, not recruiting	`NCT05404880` - INSPIRIS China PMCF Study
Recruiting	`NCT04652375` - Outcomes After Albumin vs Lactated Ringer's Solution in CABG and AVR Procedures	N/A
Recruiting	`NCT06106451` - Optimization Post-TAVR to IMprove Activity Levels (OPTIMAL Study)	N/A
Completed	`NCT00860730` - PERCEVAL Pivotal Trial	N/A
Active, not recruiting	`NCT00396760` - Comparison of Aprotinin and Tranexamic Acid in Routine Cardiac Surgery	Phase 3
Not yet recruiting	`NCT03603483` - Aortic Root Enlargement in Aortic Valve Replacement	N/A
Terminated	`NCT01368666` - Safety and Effectiveness Study of Perceval S Valve for Extended CE Mark	N/A
Recruiting	`NCT03002272` - Transcatheter Aortic Prosthesis Function: A Long-term Follow-up Study
Active, not recruiting	`NCT03258333` - Small Aortic Annulus - a New Solution to the Old Problem	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.