Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06205875

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

Led by Jessa Hospital · Updated on 2025-05-14

100

Participants Needed

1

Research Sites

201 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Scheduled for elective aortic valve surgery or elective mitral valve surgery via right anterolateral thoracotomy
  • Adult patients aged 18 years or older
  • Bodyweight greater than 50 kilograms
  • EuroScore II less than 3%
Not Eligible

You will not qualify if you...

  • Refusal to participate in the study
  • Inability to communicate due to language or neurological barriers
  • Inability to use patient-controlled intravenous analgesia or understand pain scoring due to confusion or learning difficulties
  • Chronic use of opioids
  • Chronic use of analgesic antidepressants or antiepileptic medications
  • Use of medications that may interact with bupivacaine-epinephrine or opioids (such as mexiletine, ketoconazole, theophylline, IMAO, Digitalis, or cimetidine)
  • History of major trauma or surgery on the right chest wall
  • History of chronic pain on the right chest wall
  • Allergy to opioids or local anesthetics
  • Allergy to paracetamol
  • Severe obesity (BMI 40 or more)
  • Pregnancy
  • Intraoperative events affecting early postoperative recovery (including aortic dissection, systolic anterior motion of the mitral valve, cardiac tamponade, or brady-arrhythmias needing external pacing)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Jessa hospital

Hasselt, Limburg, Belgium, 3500

Actively Recruiting

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Research Team

B

Björn Stessel, Dr

CONTACT

I

Ina Callebout, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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