Status:
RECRUITING
High Versus Low Dose Serratus Anterior Plane Block After Minimally Invasive Valve Surgery.
Lead Sponsor:
Jessa Hospital
Conditions:
Analgesia
Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
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 postoperat...
Detailed Description
During the last two decades, cardiac surgical techniques have changed dramatically. Evidence for good short and long-term outcomes after endovascular and minimally invasive procedures is rising. This ...
Eligibility Criteria
Inclusion
- 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
- 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,...)
Key Trial Info
Start Date :
February 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06205875
Start Date
February 21 2024
End Date
December 31 2027
Last Update
May 14 2025
Active Locations (1)
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1
Jessa hospital
Hasselt, Limburg, Belgium, 3500