Serratus Anterior Plane Block Versus Standard of Care After Totally Endoscopic Aortic Valve Replacement

NCT04699422 | Completed

• 1 other identifier: JessaH_SAPblock
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess and compare the efficacy of a serratus anterior plane (SAP) block and our current pain protocol (Patient Controlled Intravenous Analgesia with opioids) in the prevention and treatment of acute postoperative pain after totally endoscopic aortic valve replacement (AVR) surgery.

Conditions

Analgesia; Surgery; Cardiac Disease

Outcome Measures

Primary Outcomes (1)

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

  Piritramide consumption (mg) will be directly read from the PCIA-system after 24 hours.

  24 hours after performing the SAP block

Secondary Outcomes (15)

• 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

• Opioid free patients during hospital length of stay

  Through study completion, an average of 7 days

• Postoperative pain score in rest

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

• Quality of recovery after totally endoscopic aortic valve replacement

  Postoperative days 2 and 7

Study Arms (2)

Experimental group

ACTIVE COMPARATOR

Patients in the experimental group will receive the serratus anterior plane block combined with postoperative PCIA with Piritramide.

Procedure: Serratus anterior plane block; Drug: PCIA with Piritramide

Control group

SHAM COMPARATOR

Patients in the control group will receive postoperative PCIA with Piritramide.

Drug: PCIA with Piritramide

Interventions

Serratus anterior plane block 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,30 cc Bupivacaine 0.25% will be injected in the deep compartment. After the deep component of the SAP is completed, the needle will be withdrawn to the subcutaneous tissues.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. 10 cc Bupivacaine 0.25% will be injected superficial to the serratus muscles after correct placement of the needle tip is confirmed on ultrasound

Experimental group

PCIA with Piritramide DRUG

A patient controlled intravenous analgesia system (IVAC PCAM®, Cardinal Health or CADD pump) with piritramide (Dipidolor®, Janssen) using following settings: bolus 2 mg and lockout interval 15 min.

Also known as: PCIA with Dipidolor

Control group; Experimental 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 replacement surgery via right anterolateral thoracotomy
• Adult patients (minimally 18 years old)
• EuroScore ii \< 3%
• Bodyweight \> 50 kg

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
• 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
• Morbid obesity (BMI \> 35)
• Pregnancy
• Peroperative events compromising early postoperative recovery (aortic dissection, systolic anterior motion of the mitral valve, cardiac tamponade, ..)

Sponsors & Collaborators

• Jessa Hospital: lead

Study Sites (1)

Dr Bjorn Stessel

Hasselt, 3500, Belgium

Location

Related Publications (1)

• Vandenbrande J, Jamaer B, Stessel B, van Hilst E, Callebaut I, Yilmaz A, Packle L, Sermeus L, Blanco R, Jalil H. Serratus plane block versus standard of care for pain control after totally endoscopic aortic valve replacement: a double-blind, randomized controlled, superiority trial. Reg Anesth Pain Med. 2024 Jun 3;49(6):429-435. doi: 10.1136/rapm-2023-104439.

  PMID: 37597856 DERIVED

MeSH Terms

Conditions

Agnosia; Heart Diseases

Interventions

Pirinitramide

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Isonipecotic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring

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: Principal Investigator

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

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: January 7, 2021
• Study Start: December 3, 2020
• Primary Completion: July 4, 2022
• Study Completion: July 4, 2022
• Last Updated: December 21, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)