Interpectoral-pectoserratus Plane Block for Minimally Invasive Aortic Valve Replacement Via Right Anterior Minithoracotomy

NCT06369870 | Recruiting Phase 4

• 1 other identifier: PAINCARE
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the analgesic effect of locoregional anaesthesia, specifically the interpectoral pectoserratus plane (IPP-PSP) block, in comparison to a placebo (sham block) after Aortic Valve Replacement via Right Anterior Minithoracotomy (AVR-RAT). The main question the trial aims to answer is: Can the IPP-PSP block effectively reduce opioid consumption within the first 48 hours after AVR-RAT surgery? The purpose is to understand the impact of the IPP-PSP block on postoperative pain. Therefore, the aim is to investigate the influence of the IPP-PSP block on the amount of pain medication administered during the patients' first 48 hours after surgery. Participants, who are scheduled for AVR-RAT surgery, will be randomly assigned to receive either the IPP-PSP block or the sham block. Researchers will compare opioid consumption among other outcomes, including differences in pain scores, incidence of nausea and vomiting, quality of recovery, quality of life, and the length of hospital stay between the two groups. Patients will be monitored during their hospitalization, and a follow-up phone call will be conducted 30 days after surgery.

Conditions

Analgesic Effect

Keywords

interpectoral-pectoserratus plane block; aortic valve replacement via right anterior minithoracotomy; IPP-PSP block; AVR-RAT

Outcome Measures

Primary Outcomes (1)

• Cumulative opioid consumption

  Cumulative opioid consumption (in oral morphine milligram equivalents (OMEs)) in the first 48 postoperative hours after the completion of the surgical procedure

  in the first 48 hours after completion of the surgical procedure

Secondary Outcomes (12)

• Number of episodes of postoperative pain

  In the first 48 hours after completion of the surgical procedure

• Time to need for rescue medication

  In the first 48 hours after completion of the surgical procedure

• Number of patients with respiratory complications

  During hospital stay (on average 7 days)

• PaCO2 levels

  During the 48 postoperative hours after the completion of the surgical procedure or until Intensive Care Unit (ICU) discharge, whichever occurs first;

• Postsurgical Quality of Recovery measured by the Quality of Recovery questionnaire

  Day before, first, second and seventh day after surgery

Study Arms (2)

Levobupivacaine Hydrochloride 0.25 % Injectable Solution

ACTIVE COMPARATOR

Unilateral (right) IPP-PSP block with 30 mL levobupivacaine 0.25%, administered after the closure of the wounds. After wound closure, the IPP-PSP block is performed at the level of the 4th rib. At the pre-axillary line, the pectoralis major, the pectoralis minor and the serratus anterior muscle are identified. At first, the needle is positioned in the fascial plane between the pectoralis minor and the serratus anterior muscle. The needle position is confirmed by hydro-dissection of this plane with 2 mL of normal saline 0.9%.The 20 ml syringe with trial drug solution is injected in this pectoserratus plane (PSP). The needle tip is repositioned in the interpectoral plane between both the pectoralis major and minor muscle. The 10 ml syringe with trial drug solution is administered in this interpectoral plane (IPP).

Drug: Levobupivacaine Hydrochloride 0.25 % Injectable Solution

Sodium chloride 0.9%

SHAM COMPARATOR

Unilateral (right) IPP-PSP block with 30 mL normal saline 0.9%, administered after the closure of the wounds. Unilateral (right) IPP-PSP block with 30 mL normal saline 0.9%, administered after the closure of the wounds. The IPP-PSP block procedure will be carried out as described in the Active Comparator.

Drug: Sodium chloride 0.9%

Interventions

Levobupivacaine Hydrochloride 0.25 % Injectable Solution DRUG

After wound closure, the IPP-PSP block is performed at the level of the 4th rib. At the pre-axillary line, the pectoralis major, the pectoralis minor and the serratus anterior muscle are identified. At first, the needle is positioned in the fascial plane between the pectoralis minor and the serratus anterior muscle. The needle position is confirmed by hydro-dissection of this plane with 2 mL of normal saline 0.9%.The 20 ml syringe with trial drug solution is injected in this pectoserratus plane (PSP). The needle tip is repositioned in the interpectoral plane between both the pectoralis major and minor muscle. The 10 ml syringe with trial drug solution is administered in this interpectoral plane (IPP).

Also known as: IPP-PSP block, Intervention group

Levobupivacaine Hydrochloride 0.25 % Injectable Solution

Sodium chloride 0.9% DRUG

Unilateral (right) IPP-PSP block with 30 mL normal saline 0.9%, administered after the closure of the wounds. The IPP-PSP block procedure will be carried out as described in the intervention description of the IPP-PSP block.

Also known as: Sham block, Control group

Sodium chloride 0.9%

Eligibility Criteria

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

You may qualify if:

• Adult patients (18 years of age or older);
• Patients scheduled for minimally invasive aortic valve replacement via right anterior minithoracotomy;
• Patients with American Society of Anesthesiologists (ASA) physical status classification II, III or IV;
• Patients with European System for Cardiac Operative Risk Evaluation (EuroSCORE) 2 ≤ 4%;
• Patient has given written, free and informed consent.

You may not qualify if:

• BMI \> 35;
• Patients under legal protection (curatorship, guardianship);
• Patients subject to a legal protection measure;
• An adult who is incapable or unable to give consent;
• Patients requiring emergency surgery within 24 hours;
• Chronic opioid use (\> 3 administrations per week or continuous transdermal therapy, longer than the last 3 months);
• Patients known with chronic pain;
• Patients known with an allergy to levobupivacaine or drugs used as standard of care, including amongst others piritramide, dexamethasone, propofol, remifentanil, rocuronium, acetaminophen, ondansetron;
• Patients who receive medication that could possibly interact with levobupivacaine (mexiletine, ketoconazole, theophylline);
• Patients who took monoamine oxidase (MAO) inhibitors within the last 2 weeks before surgery;
• Patients with chronic renal failure (dialysis dependent, estimated glomerular filtration rate (eGFR) \< 30 ml.min-1.(1,73 m²)-1) ;
• Patients with severe hepatic impairment (Model for End-Stage Liver Disease (MELD) score ≥ 20);
• Patients with preoperative cognitive dysfunction (Mini Mental State Examination (MMSE) score \< 24);
• Patients with uncontrolled epilepsy;
• Patients with severe arterial hypotension (Systolic Arterial Pressure (SAP) \< 90 mmHg, cardiogenic shock);

Sponsors & Collaborators

• Algemeen Ziekenhuis Maria Middelares: lead

Study Sites (1)

AZ Maria Middelares

Ghent, East-Flanders, 9000, Belgium

RECRUITING

MeSH Terms

Interventions

Levobupivacaine; Sodium Chloride; Control Groups

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Bart Vaes, MD

  Algemeen Ziekenhuis Maria Middelares

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bart Vaes, MD

CONTACT

0032 9 246 17 00; bart.vaes@mijnziekenhuis.be

Ella Hermie, MSc

CONTACT

0032 9 246 17 03; ella.hermie@mijnziekenhuis.be

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Neither the participant, anesthesiologist, study nurse, surgeon, nor the doctors and nurses in the Intensive Care Unit will know the participant's group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The trial is designed as a single-center, prospective, double-blind, randomized controlled superiority trial. Patients will be randomly assigned to either the IPP-PSP block group or the sham block group (placebo).

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 17, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

BE (1)