Clinical trial
Interpectoral-pectoserratus Plane Block for Minimally Invasive Aortic Valve Replacement Via Right Anterior Minithoracotomy: a Single Centre, Prospective, Double-blind, Randomized Controlled Superiority Trial
Name
PAINCARE
Description
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.
Trial arms
Trial start
2024-07-01
Estimated PCD
2027-11-01
Trial end
2027-12-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Levobupivacaine Hydrochloride 0.25 % Injectable Solution
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).
Arms:
Levobupivacaine Hydrochloride 0.25 % Injectable Solution
Other names:
IPP-PSP block, Intervention group
Sodium chloride 0.9%
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.
Arms:
Sodium chloride 0.9%
Other names:
Sham block, Control group
Size
144
Primary endpoint
Cumulative opioid consumption
in the first 48 hours after completion of the surgical procedure
Eligibility criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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);
* Patients who simultaneously participate in another interventional clinical trial;
* Soft tissue infection in the area of the procedure;
* Patients who are pregnant, parturient or breast-feeding women;
* Patients who are unable to sufficiently speak and write in the Dutch language.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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).', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': "Neither the participant, anesthesiologist, study nurse, surgeon, nor the doctors and nurses in the Intensive Care Unit will know the participant's group assignment.", 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 144, 'type': 'ESTIMATED'}}
Updated at
2024-04-17
1 organization
2 products
1 indication
Organization
Algemeen Ziekenhuis Maria MiddelaresIndication
Analgesic EffectProduct
Sodium chloride