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Compares treatment options for Analgesia
Official title High Versus Low Dose Serratus Anterior Plane Block After Minimally Invasive Valve Surgery.
ClinicalTrials.gov ID: NCT06205875
What this study is testing
What is PCIA with morphine?
PCIA with morphine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for analgesia.
Also referred to as PCIA with Sterop.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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%
You likely can't join if
- 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...
See the full eligibility 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%
- 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,...)
The study team makes the final eligibility decision.
Where it's taking place
- Hasselt, Limburg, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hasselt, Limburg, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.