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Search / Trial NCT06205875

High Versus Low Dose Serratus Anterior Plane Block After Minimally Invasive Valve Surgery.

Launched by JESSA HOSPITAL · Jan 4, 2024

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

Aorta/Mitral Valve Surgery Serratus Anterior Plane Block Enhanced Recovery After Surgery Post Operative Pain

ClinConnect Summary

This clinical trial is comparing two different doses of a pain relief technique called the serratus anterior plane (SAP) block for patients undergoing minimally invasive heart surgery, specifically aortic or mitral valve surgery. The study aims to find out if a higher dose of the SAP block provides better pain relief after the surgery compared to the standard dose. This is important because effective pain management can help patients recover more comfortably.

To be eligible for this study, participants need to be adults (at least 18 years old) scheduled for elective heart surgery through a specific surgical approach and weigh more than 50 kg. They should also have a low risk of complications, as defined by a scoring system. Participants in the trial can expect to receive either the high or standard dose of the SAP block before surgery and will be closely monitored for how well their pain is managed afterward. It's essential for potential participants to understand that certain medical conditions, medications, or allergies may disqualify them from joining the study. Overall, this trial seeks to improve pain management strategies after heart surgery, helping patients have a better recovery experience.

Gender

ALL

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,...)

About Jessa Hospital

Jessa Hospital is a leading healthcare institution dedicated to advancing medical research and improving patient outcomes through innovative clinical trials. With a commitment to excellence in patient care and a strong emphasis on collaborative research, Jessa Hospital fosters an environment where cutting-edge therapies and treatments can be evaluated rigorously. The hospital's multidisciplinary team of experienced healthcare professionals and researchers works diligently to uphold the highest ethical standards, ensuring the safety and well-being of participants while contributing to the broader medical community. Through its robust clinical trial program, Jessa Hospital aims to translate scientific discoveries into effective healthcare solutions, ultimately enhancing the quality of care for patients.

Locations

Hasselt, Limburg, Belgium

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported