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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05107453
Other study ID # MMS.2021.042
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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