Interpectoral-pectoserratus plane block for minimally invasive aortic valve replacement via right anterior minithoracotomy

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Az Maria Middelares Gent

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Trial duration

1 Sep 2024 → ongoing

Decision date (initial)

2024-06-26

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To compare the analgesic effect of an interpectoral-pectoserratus plane (IPP-PSP) block in patients undergoing minimally invasive aortic valve replacement via right anterior minithoracotomy (AVR-RAT) with a control group (with sham block).

Secondary objectives 11

1. To compare an IPP-PSP block to a control group with a sham block for AVR-RAT in terms of the quality of postoperative analgesia in the first 48 postoperative hours after the completion of the surgical procedure
2. To compare an IPP-PSP block to a control group with a sham block for AVR-RAT in terms of the time to the first administration of rescue medication for breakthrough pain (e.g. tramadol, oxycodone) in the first 48 postoperative hour after the completion of the surgical procedure
3. To compare an IPP-PSP block to a control group with a sham block for AVR-RAT in terms of the time to extubation in the Intensive Care Unit (ICU)
4. To compare an IPP-PSP block to a control group with a sham block for AVR-RAT in terms of occurrence of non-serious side effects associated with opioid administration: respiratory complications, postoperative nausea and vomiting in the first 48 postoperative hours after the completion of the surgical procedure
5. To compare an IPP-PSP block to a control group with a sham block for AVR-RAT in terms of quality of post-surgical recovery on the first, second and seventh postoperative day
6. To compare an IPP-PSP block to a control group with a sham block for AVR-RAT in terms of postoperative length of stay in the ICU
7. To compare an IPP-PSP block to a control group with a sham block for AVR-RAT in terms of the total postoperative hospital stay
8. To compare an IPP-PSP block to a control group with a sham block for AVR-RAT in terms of the arterial partial carbon dioxide pressure (PaCO2) levels measured every 4 hours during the 48 postoperative hours or until ICU discharge, whichever occurs first
9. To compare an IPP-PSP block to a control group with a sham block for AVR-RAT in terms of quality of life preoperative and at 30 days after surgery
10. To compare an IPP-PSP block to a control group with a sham block for AVR-RAT in terms of days alive and at home at 30 days after surgery
11. To compare an IPP-PSP block to a control group with a sham block for AVR-RAT in terms of mortality at 30 days after surgery

Conditions and MedDRA coding

Aortic Valve disease

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

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

Exclusion criteria 19

1. BMI > 35
2. Patients with chronic renal failure (dialysis dependent, estimated glomerular filtration rate (eGFR) < 30 ml.min-1.(1,73 m²)-1)
3. Patients with severe hepatic impairment (Model for End-Stage Liver Disease (MELD) score ≥ 20)
4. Patients with pre-existing cognitive dysfunction (documented by geriatric or neurologic assessment)
5. Patients with uncontrolled epilepsy
6. Patients with severe arterial hypotension (Systolic Arterial Pressure (SAP) < 90 mmHg, cardiogenic shock)
7. Patients who simultaneously participate in another interventional clinical trial
8. Soft tissue infection in the area of the procedure
9. Patients who are pregnant, parturient or breast-feeding women
10. Patients who are unable to sufficiently speak and write in the Dutch language
11. Patients under legal protection (curatorship, guardianship)
12. Patients subject to a legal protection measure
13. An adult who is uncapable or unable to give consent
14. Patients requiring emergency surgery within 24 hours
15. Chronic opioid use (> 3 administrations per week or continuous transdermal therapy, longer than the last 3 months)
16. Patients known with an allergy to levobupivacaine or drugs used as standard of care, including amongst others piritramide, dexamethasone, propofol, remifentanil, rocuronium, paracetamol, ondansetron
17. Patients who receive medication that could possibly interact with levobupivacaine (mexiletine, ketoconazole, theophylline)
18. Patients who took monoamine oxidase (MAO) inhibitors within the last 2 weeks before surgery
19. Patients known with chronic pain

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The cumulative opioid consumption in the first 48 postoperative hours after the completion of the surgical procedure in patients undergoing AVR-RAT procedures which is expressed in OMEs

Secondary endpoints 12

1. Number of episodes of postoperative pain (NRS score ≥ 4) at rest and at deep inspiration in the first 48 postoperative hours after the completion of the surgical procedure
2. Time to need for rescue medication for breakthrough pain (e.g. tramadol, oxycodone) in the first 48 postoperative hours after the completion of the surgical procedure
3. Number of patients with respiratory complications, leading to non-invasive ventilation (NIV) or high-flow nasal cannula (HFNC) oxygen therapy, orotracheal intubation for more than 24 hours or orotracheal re-intubation
4. Levels of PaCO2 measured every 4 hours during the 48 postoperative hours after the completion of the surgical procedure or until ICU discharge, whichever occurs first
5. Postsurgical recovery by QoR-15NL questionnaire on day before, first, second and seventh day after surgery
6. Number of episodes of PONV in the first 48 postoperative hours
7. Time to extubation of the patient in the ICU
8. Number of hours spent in the ICU (until ready for discharge)
9. Number of days in the hospital between surgery and first hospital discharge
10. The quality of life (QoL) by the EQ-5D questionnaire on the day before surgery and 30 days after surgery
11. Number of days alive and at home after surgery (DAH30)
12. Vital status at 30 days after surgery

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Az Maria Middelares Gent

Sponsor organisation

Az Maria Middelares Gent

Address

Buitenring-Sint-Denijs 30

City

Gent

Postcode

9000

Country

Belgium

Scientific contact point

Organisation

Az Maria Middelares Gent

Contact name

Ella Hermie

Public contact point

Organisation

Az Maria Middelares Gent

Contact name

Steffi Ryckaert

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications