Serratus Planus Block After Minimally Invasive Cardiac Surgery (NCT06746272) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Serratus Planus Block After Minimally Invasive Cardiac Surgery
Austria66 participantsStarted 2023-01-01
Plain-language summary
Many patients receiving MICS (minimally invasive cardiac surgery) suffer from significant postsurgical pain. While systemic analgesic therapy has been proven to be insufficient in a great number of patients, significant unwanted side effects might occur. Therefore, the investigation of peripheral nerve blocks such as SAPB with potential for high benefit and low risk for adverse effects as new treatment options for thoracotomy-pain is relevant. Previous randomized double-blind investigations of this novel technique are lacking. At this moment our department's current standard of care is that, SAPB is performed in patients after MICS in our department if the treating anesthetist is experienced in the procedure and the patient receives i.v. analgesia only without nerve block is he or she is not. If we are able to show a benefit for patients in the SAPB arm, the nerve block may constitute a new standard of care for all MICS patients no only in our department but also after MICS in general.
Patients ≥18 years of age, being treated in the cardiothoracic ICU after elective cardiac surgery performed via lateral minithoracotomy (mitral valve, tricuspid valve, atrial septal defect closure) will be included after signed informed consent before surgery. Allocation concealment is guaranteed by opening of the concealed envelope and performance of the ultrasound guided SAPB or ultrasound only by medical personnel not involved in any of the study procedures.
Randomization will be carried out by a web-based software ('randomizer,). The intervention will be performed after ICU arrival but under sedation and analgesia before extubation to minimize patient discomfort and to ensure double blinding.
Efficacy will be evaluated using Pain Scoring by visual analogue scale (VAS), opioid requirements, postoperative complications, need for rescue analgesia, lung function tests and markers of myocardial stress and inflammatory parameters in the early postoperative period according to our current protocol in the ICU.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18 years of age or more
* patients undergoing cardiac surgery through a thoracotomy incision
* patients having surgery performed by a Cardiac Surgeon at the Medical University of Vienna
* patients being treated in the 16 bed primary cardiothoracic ICU 13B-HTG at the Medical University of Vienna
* patients being treated in the 4 bed PACU of the cardiothoracic and vascular anesthesia department at the Medical University of Vienna
* signed patient consent prior to surgery
Exclusion Criteria:
* patients requiring full sternotomy or emergency surgery
* Allergy to amid-type local anesthetics
* patients less that 18 years of age at the time of surgery
* patients intubated \>48h prior to surgery
* Infection at the site of the Serratus Anterior Plane Block
* Known bleeding diathesis with increased risk of hematoma at the block site
* Known opioid abuse
* Allergy to (metamizole AND acetaminophen) OR (hydromorphone AND Piritramide)
* Active pulmonary infection at the time of surgery
* Patient refusal prior to surgery
* Inability to communicate
* BMI ≥40
* Patients with known dementia or/and a legal guardian for medical issues
* Patients unable to understand the study measures and are not able to complete pain assessment forms.
* Known pregnancy
* Severe cardiorespiratory disturbances such as high respiratory support (\>0,7 FiO2 or driving pressure \>25mbar) or high catecholamine support (\>0,5mcg/kg/min Norepinephrine and/or \>5IE Vasopressin/h) making fast trac…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Postoperative Pain Score: VAS 0-10
Timeframe: 12 hours after successful respiratory weaning