High versus low dose serratus anterior plane block after minimally invasive valve surgery

Phase 1

• Conditions: Serratus anterior plane block after an aortic valve replacement; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]

• Registration Number: CTIS2023-508719-22-00
• Lead Sponsor: Jessa Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-31
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Scheduled for elective aortic valve surgery or elective mitral valve surgery via right anterolateral thoracotomy, Adult patients (minimally 18 years old), EuroScore ii < 3%

Exclusion Criteria

Refusal to participate, Class 3 obesity (BMI 40 or more), Intraoperative events compromising early postoperative recovery (aortic dissection, systolic anterior motion of the mitral valve, cardiac tamponade, ..), Pregnancy, 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 analgesic antidepressants and/or antiepileptics, Chronic use of opioids, 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 acetaminophen

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: We hypothesize a 25% reduction in opioid consumption in patients randomized to the high dose local anesthesia intervention arm towards patients in the control arm.;Secondary Objective: Secondly, we hypothesize a trend towards differences in secondary outcome parameters and we hypothesize serum bupivacaine levels to not exceed toxic levels after Serratus Anterior Plane Block.;Primary end point(s): Cumulative morphine consumption by PCIA at 24 hours after block placement. Information on morphine consumption will extracted from the PCIA-system after 24 hours and analyzed using 4-hour intervals.