RecruitingNot ApplicableNCT06205875

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

High Versus Low Dose Serratus Anterior Plane Block After Minimally Invasive Valve Surgery: a Double-blinded Randomized Controlled Trial.

Sponsor

Jessa Hospital

Enrollment

100 participants

Start Date

Feb 21, 2024

Study Type

INTERVENTIONAL

Conditions

Surgery Post Operative Pain Analgesia Cardiac Disease

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether a higher or lower dose of a nerve block (called a serratus anterior plane block) works better to control pain after heart valve surgery done through a small incision on the right side of the chest. Researchers want to find out which dose reduces pain more effectively. **You may be eligible if...** - You are 18 or older and weigh more than 50 kg (about 110 lbs) - You are scheduled for elective aortic or mitral valve surgery through a right-side chest incision - Your surgical risk score (EuroScore II) is low (under 3%) **You may NOT be eligible if...** - You are unable to communicate or understand the study - You have allergies to local anesthetics - You have certain bleeding disorders or infections at the injection site Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREHigh dose serratus anterior plane block (2.4 mg/kg patient ideal body weight)

The needle will be introduced in-plane from supero-anterior to postero-inferior until the needle tip is positioned in the plane underneath the serratus muscle (deep compartment). Under continuous ultrasound guidance, 3/4th of the bupivacaine 0.25% plus epinephrine solution will be injected in the deep compartment. After the deep component of the serratus anterior plane block is completed, the needle will be withdrawn to the subcutaneous tissues. The needle will be flattened and advanced in-plane to the plane superficial to the serratus muscles. The remainder quarter of the bupivacaine 0.25% plus epinephrine solution will be injected superficial to the serratus muscles after correct placement of the needle tip is confirmed on ultrasound. In total a dose of 2.4mg/kg patient ideal body weight will be administered. There is a maximal dose of 200 mg adrenalized bupivacaine for patients with an ideal body weight of 83 kg or more.

PROCEDURELow dose serratus anterior plane block (1.2mg/kg patient ideal body weight)

The needle will be introduced in-plane from supero-anterior to postero-inferior until the needle tip is positioned in the plane underneath the serratus muscle (deep compartment). Under continuous ultrasound guidance, 3/4th of the bupivacaine 0.25% will be injected in the deep compartment. After the deep component of the serratus anterior plane block is completed, the needle will be withdrawn to the subcutaneous tissues. The needle will be flattened and advanced in-plane to the plane superficial to the serratus muscles. The remainder quarter of the bupivacaine 0.25% will be injected superficial to the serratus muscles after correct placement of the needle tip is confirmed on ultrasound.

DRUGPCIA with morphine

A patient controlled intravenous analgesia system (Bodyguard 595 Colorvision®) with morphine (Sterop®) using following settings: bolus 1.5 mg and lockout interval 7 min with maximal dose of 30mg per 4 hours.