NCT06205875 High Versus Low Dose Serratus Anterior Plane Block After Minimally Invasive Valve Surgery.
| NCT ID | NCT06205875 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jessa Hospital |
| Condition | Analgesia |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-02-21 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-02-21 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to compare the efficacy and quality of pain relief provided by the high-dose serratus anterior plane (SAP) block with the standard SAP block in preventing and treating acute postoperative pain after total endoscopic aortic or mitral valve surgery.
Eligibility Criteria
Inclusion Criteria: * Scheduled for elective aortic valve surgery or elective mitral valve surgery via right anterolateral thoracotomy * Adult patients (minimally 18 years old) * Bodyweight \> 50kg * EuroScore ii \< 3% Exclusion Criteria: * Refusal to participate * Inability to communicate due to language or neurologic barriers * Inability to control and self-administer opioids with PCIA or to comprehend the NRS pain score due to confusion or learning difficulties * Chronic use of opioids * Chronic use of analgesic antidepressants and/or antiepileptics * Use of prohibited medication which possibly interacts with bupivacaine-epinephrine or opioids (mexiletine, ketoconazole, theophylline, IMAO, Digitalis and cimetidine) * History of major trauma or surgery to right chest wall * History of chronic pain at right chest wall * Allergy to opioids and/or local anesthetics * Allergy to paracetamol * Class 3 obesity (BMI 40 or more) * Pregnancy * Intraoperative events compromising early postoperative recovery (aortic dissection, systolic anterior motion of the mitral valve, cardiac tamponade, brady-arrhytmias requiring external pacing,...)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06205875 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Analgesia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06205875 currently recruiting?
Yes, NCT06205875 is actively recruiting participants. Contact the research team at bjorn.stessel@jessazh.be for enrollment information.
Where is the NCT06205875 trial being conducted?
This trial is being conducted at Hasselt, Belgium.
Who is sponsoring the NCT06205875 clinical trial?
NCT06205875 is sponsored by Jessa Hospital. The trial plans to enroll 100 participants.