Comparing high and low dose pain relief methods after heart valve surgery
High Versus Low Dose Serratus Anterior Plane Block After Minimally Invasive Valve Surgery: a Double-blinded Randomized Controlled Trial.
This study is testing whether a high or low dose of a new pain relief method can help patients after heart valve surgery feel less pain and use fewer opioids.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jessa Hospital Academic / other |
| Locations | 1 site (Hasselt, Limburg) |
| Trial ID | NCT06205875 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults scheduled for elective aortic or mitral valve surgery who weigh more than 50 kg and have a EuroScore II of less than 3%.
Not a fit: Patients with chronic pain issues, significant obesity, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce postoperative pain and opioid use, leading to faster recovery for patients after heart valve surgery.
How similar studies have performed: Previous studies have shown promising results with the SAP block in similar surgical contexts, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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,...)
Where this trial is running
Hasselt, Limburg
- Jessa hospital — Hasselt, Limburg, Belgium (Recruiting)
Study contacts
- Study coordinator: Björn Stessel, Dr
- Email: bjorn.stessel@jessazh.be
- Phone: 003211222107
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.