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

NCT06205875 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-05-14

No results posted yet for this study

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.

Conditions

  • Analgesia
  • Surgery
  • Cardiac Disease
  • Post Operative Pain

Interventions

PROCEDURE

High 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 After the deep component of the serratus anterior plane block is completed, the needle will be withdrawn to the subcutaneous tissues.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.

PROCEDURE

Low 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 After the deep component of the serratus anterior plane block is completed, the needle will be withdrawn to the subcutaneous tissues.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.

DRUG

PCIA 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.

Sponsors & Collaborators

  • Jessa Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-21
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06205875 on ClinicalTrials.gov