Comparing high and low dose pain relief methods after heart valve surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study compares the effectiveness of high-dose versus low-dose serratus anterior plane (SAP) blocks in managing postoperative pain for patients undergoing minimally invasive aortic or mitral valve surgery. The SAP block is an innovative pain relief technique that targets specific muscles to reduce the need for opioids, which can have undesirable side effects. By evaluating pain relief and opioid consumption, the study aims to enhance recovery protocols for cardiac surgery patients. Participants will receive either a high or low dose of the SAP block, alongside patient-controlled analgesia (PCIA) with morphine.

Why it matters

Who can join: the full rules

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,...)

Where it's running

• Jessa hospital
  Hasselt, Limburg, Belgium Recruiting

Study contacts

• Study coordinator: Björn Stessel, Dr
• Email: bjorn.stessel@jessazh.be
• Phone: 003211222107

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.