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

NCT06205875 | Recruiting

• 1 other identifier: f/2023/119
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Aorta/mitral valve surgery; Serratus anterior plane block; Enhanced recovery after surgery; post operative pain

Outcome Measures

Primary Outcomes (1)

• Cumulative opioid consumption by patient-controlled intravenous analgesia (PCIA)

  Morphine consumption will be directly read from the PCIA-system after 24 hours

  24 hours after block placement

Secondary Outcomes (13)

• Opioid consumption during predetermined time intervals after surgery

  Every 4 hours until 24 hours after placement of the SAP block

• Opioid free patients first 24 postoperative hours

  First 24 hours

• Postoperative pain score in rest and on deep respiration

  4, 8, 12 and 24 hours after performing the SAP block and at postoperative day 7.

• Overall patient Satisfaction with analgesic therapy

  24 hours after performing the SAP block at postoperative day 1.

• Time to extubation

  Throughout study completion, an average of 7 days

Study Arms (2)

Intervention group

EXPERIMENTAL

Patients in the intervention group will receive a mixture of high-dose local anesthetic and epinephrine administered via a serratus anterior plane block.

Procedure: High dose serratus anterior plane block (2.4 mg/kg patient ideal body weight); Drug: PCIA with morphine

Control group

ACTIVE COMPARATOR

Patients in the control group will receive a serratus anterior plane block with a low dose local anesthetic (based upon our primary trial).

Procedure: Low dose serratus anterior plane block (1.2mg/kg patient ideal body weight); Drug: PCIA with morphine

Interventions

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

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.

Intervention group

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

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.

Control group

PCIA with morphine DRUG

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.

Also known as: PCIA with Sterop

Control group; Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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,...)

Sponsors & Collaborators

• Jessa Hospital: lead

Study Sites (1)

Jessa hospital

Hasselt, Limburg, 3500, Belgium

RECRUITING

MeSH Terms

Conditions

Agnosia; Heart Diseases; Pain, Postoperative

Interventions

Morphine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Björn Stessel, Dr

CONTACT

003211222107; bjorn.stessel@jessazh.be

Ina Callebout, PhD

CONTACT

003211339848; ina.callebaut@jessazh.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: This trial is designed as a mono-center, double-blinded, prospective, randomized controlled superiority trail comparing 2 groups of patients

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 16, 2024
• Study Start: February 21, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)