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

NCT ID: NCT06205875

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-21
• Study Completion Date: 2027-12-31

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.

Detailed Description

During the last two decades, cardiac surgical techniques have changed dramatically. Evidence for good short and long-term outcomes after endovascular and minimally invasive procedures is rising. This shift made it possible to avoid sternotomy and thus facilitating earlier patient recovery without compromising safety. Therefore, enhanced recovery after surgery (ERAS) protocols have been implemented to aim for early extubation and ambulation. While policies for early extubation and discharge from the hospital have been implemented, the analgesic regimen has not been modified. Opioids remain the standard treatment in the postoperative setting after cardiac surgery despite known side effects such as nausea, constipation and the risk of addiction. Neuraxial anaesthesia techniques, which require fewer opioids in cardiac surgery, have been studied and validated but not yet implemented.

In 2013, the serratus anterior plane (SAP) block was described as a pain relief option for chest surgery. This anaesthesia technique injects local anaesthetics under the serratus muscle and between the latissimus dorsi and serratus anterior using ultrasound. Successful pain relief with this SAP block has been reported in thoracotomy, chest surgery, and rib fractures. In our previous study, we demonstrated a 40% reduction in morphine consumption during the first 24 hours after total endoscopic aortic valve replacement with an SAP block compared to a control group without an SAP block. Lower pain scores were also observed in the SAP group

As such, in this proposed study, we aim to optimise the intensity of the Serratus anterior plane block (SAPB) to decrease opioid requirements further and to encounter more favourable secondary clinical outcome parameters. One strategy to increase the duration of action of plane blocks is injecting higher doses of local anaesthetics. A meta-analysis by De Oliveira et al. on transabdominal plane (TAP)-blocks for abdominal surgery showed a correlation between the local anaesthetic dose and the late block effect, impacting both pain scores and opioid consumption. In a randomised controlled trial by Suresh, a TAP block with bupivacaine 1.25 mcg/kg was compared to a TAP block with bupivacaine 2.5 mcg/kg, revealing a longer duration of analgesia and a lower need for additional analgesics up to 24 hours post-surgery. Moreover, loading doses up to 2mg/kg body weight are recommended for truncal blocks in general, but the mean injected dose in our intervention group was 1.25mg/kg, considering a mean patient body weight of 79.2kg. Notably, a pharmacokinetic study by Maximos and colleagues on an adrenalised bupivacaine mixture after pectointercostal fascial plane block (PIFB) after cardiac surgery showed that, despite injecting 2mcg/kg adrenalised bupivacain, both total and free arterial serum bupivacaine levels were 10-20 times lower than levels associated with neurologic or cardiovascular toxicity in the literature.

In conclusion, we are convinced we can safely improve the late effects of our SAPB compared to our first study by increasing the dose of the local anesthetic injectate.

Conditions

Analgesia; Surgery; Cardiac Disease; Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention group

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

PCIA with morphine

Intervention Type: 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.

Control group

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

PCIA with morphine

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

Other Intervention Names

PCIA with Sterop

Eligibility Criteria

Inclusion Criteria

• 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%

Exclusion Criteria

• 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,...)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jessa Hospital

OTHER

Sponsor Role: lead

Responsible Party

Stessel Björn

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jessa hospital

Hasselt, Limburg, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Björn Stessel, Dr

Role: CONTACT

bjorn.stessel@jessazh.be

003211222107

Ina Callebout, PhD

Role: CONTACT

ina.callebaut@jessazh.be

003211339848

Facility Contacts

Björn Stessel, Dr.

Role: primary

bjorn.stessel@jessazh.be

003211339856

Ina Callebaut, PhD

Role: backup

ina.callebaut@jessazh.be

003211339848

Other Identifiers

f/2023/119

Identifier Type: -

Identifier Source: org_study_id