Minimal Invasive Cardiac SurgeryPhase 4NCT05107453
Serratus Anterior Plane Block for Minimal Invasive Cardiac Surgery
A Phase 4 study testing Levobupivacaine in people with Minimal Invasive Cardiac Surgery and Mitral Valve Surgery, run by Algemeen Ziekenhuis Maria Middelares at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Minimal Invasive Cardiac Surgery, Mitral Valve Surgery, Aortic Valve Replacement
- What is being tested?
- Levobupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Oct 2021to 13 Feb 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for mitral valve surgery via port access, aortic valve replacement via right anterior thoracotomy and minimal invasive direct coronary artery bypass
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Minimal Invasive Cardiac Surgery, Mitral Valve Surgery, Aortic Valve Replacement, Minimal Invasive Direct Coronary Artery Bypass
- Being tested
- Levobupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevobupivacaineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Levobupivacaine |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic effect of superficial SAPB in MICS
Numeric (pain) Rating Scale every 2 hours
Measured: In the first 48 hours after surgery
Analgesic effect of superficial SAPB in MICS
Total opioid consumption in the intensive care unit
Measured: In the first 48 hours after surgery
Secondary outcomes (4)
Incidence of postoperative nausea and vomiting (PONV)
PONV every 2 hours
Measured: In the first 48 hours after surgery
Time to extubation in the intensive care unit
Measured: From arrival on the ICU until discharge on the ICU
ICU length of stay
Measured: From arrival on the ICU until discharge on the ICU
PaCO2
PaCO2 every 4 hours, calculated by an arterial blood gas test
Measured: In the first 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start28 Oct 2021
- Primary completion13 Feb 2023
- Study completion13 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minimal Invasive Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Algemeen Ziekenhuis Maria Middelares
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bart Vaes, MD, Algemeen Ziekenhuis Maria Middelares
- Investigators
- Steffi Ryckaert, MSc, Study director, Algemeen Ziekenhuis Maria Middelares
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05107453
- Sponsor's protocol ID
- MMS.2021.042
- Status last verified
- Aug 2024
- First submitted
- 28 Oct 2021
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serratus Anterior Plane Block for Minimal Invasive Cardiac Surgery: a Single Center Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT05107453
- Acronym / sponsor ID
- MMS.2021.042
- Conditions
- Minimal Invasive Cardiac Surgery, Mitral Valve Surgery, Aortic Valve Replacement, Minimal Invasive Direct Coronary Artery Bypass
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Algemeen Ziekenhuis Maria MiddelaresUniversity, hospital or other
- Study start
- 28 Oct 2021 (actual)
- Primary completion
- 13 Feb 2023 (actual)
- Study completion
- 13 Feb 2023 (actual)
- First posted
- 4 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAPB | Active comparator | Drug: LevobupivacaineThe 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. |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for mitral valve surgery via port access, aortic valve replacement via right anterior thoracotomy and minimal invasive direct coronary artery bypass
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevobupivacaineThe 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. | Drug | SAPB |
Primary outcome
Analgesic effect of superficial SAPB in MICS
Time frame: In the first 48 hours after surgery
Numeric (pain) Rating Scale every 2 hours
Analgesic effect of superficial SAPB in MICS
Time frame: In the first 48 hours after surgery
Total opioid consumption in the intensive care unit
4 secondary outcomes
Incidence of postoperative nausea and vomiting (PONV)
Time frame: In the first 48 hours after surgery
Time to extubation in the intensive care unit
Time frame: From arrival on the ICU until discharge on the ICU
ICU length of stay
Time frame: From arrival on the ICU until discharge on the ICU
PaCO2
Time frame: In the first 48 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steffi Ryckaert, MSc study director
Algemeen Ziekenhuis Maria Middelares
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levobupivacaine in people with Minimal Invasive Cardiac Surgery and Mitral Valve Surgery, run by Algemeen Ziekenhuis Maria Middelares at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesic effect of superficial SAPB in MICS (time frame: In the first 48 hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024; AzTrials last refreshed its copy on 26 Oct 2026.