Evaluation of the effect of para-sternal block on respiratory function after cardiac sternotomy surgery. Study prospective, controlled, randomized, single-blind study with independent assessment of outcome

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire Amiens Picardie

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

completed 31 Oct 2024

Decision date (initial)

2024-05-07

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-513301-30-00

EudraCT number

2022-000833-18

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

Compare the impact of locoregional anesthesia parasternal analgesic block on postoperative respiratory function
at D1 postoperatively.

Secondary objectives 10

1. Postoperative pain at 6, 12, 24, 30 and 48 hours postoperative
2. Pulmonary function at Day 2 and 2 months post-operative
3. Postoperative pain during respiratory physiotherapy within 48 hours postoperatively
4. Postoperative pain at daily rest from postoperative day 3 to day 7
5. The occurrence of postoperative respiratory complications within 2 months of surgery
6. Duration of mechanical ventilation.
7. Total postoperative morphine consumption within 48 hours post-op.
8. Lung Injury by plasma biomarker assay.
9. Length of hospital stay
10. occurrence of chronic pain at 2 months.

Conditions and MedDRA coding

cardiac surgery

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Patients over 18 years of age
2. Elective cardiac surgery under CEC with sternotomy (valve replacement, coronary artery bypass graft or combined combined surgery with valve replacement and coronary bypass surgery)
3. Patient's written informed consent

Exclusion criteria 14

1. Thoracotomy approach
2. Mini-sternotomy approach
3. Opioid dependence or chronic medication opioid medication
4. Chronic use of benzodiazepines (respiratory depressant or respiratory depressant or may affect respiratory function respiratory function)
5. Contraindication or allergy to local anesthetics
6. Emergency surgery
7. Acute infectious endocarditis
8. Immunosuppressive treatment or steroids (prednisone > 0.5mg/kg/day or equivalent)
9. AIDS with CD4 count <200/mm3
10. Autoimmune disorder
11. Transplant recipient
12. Inclusion in another study within the last 30 days
13. Pregnancy
14. Women of childbearing age should have a negative urine HCG pregnancy test

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. variation (reduction) in postoperative forced vital capacity (FVC) between preoperative measurement and at D1 post-op. Forced vital capacity is measured by SPIROLAB spirometry SPIROLAB spirometry and is expressed as a % of the theoretical value.

Secondary endpoints 14

1. Pulmonary function at D2 and 2 months postoperatively. Variables measured included FVC, FEV1, FEV1/FVC, peak expiratory flow (PEF), peak expiratory flow at FVC point 25 (PEF25), PEF50, PEF75, PEF25-75 and PEF75-85.
2. Postoperative pain at 6, 12, 24, 30 and 48 hours will be assessed using a numerical rating scale (EN) graded from 0 to 10. The pain will be classified as "nil" at 0, "mild" from 1 to 3, "moderate" from 4 to 6, "severe" from 7 to 10.
3. During the respiratory physiotherapy session, postoperative pain in the first 48 hours will be assessed using the EN
4. Daily postoperative pain from day 3 to day 7 will be assessed once between 8 a.m. and 12 p.m. using the EN
5. The following postoperative pulmonary complications will be detected within 2 months postoperatively and defined according to international criteria (European Perioperative Clinical Outcome definitions): - Respiratory infection (antibiotics in case of suspected suspected infection with one or more of the following: new or modified sputum, pulmonary opacities new or altered, fever fever, white blood cell count >12 × 109.litre-1).
6. Respiratory failure (postoperative PaO2 <60 mm Hg on room air, PaO2/FiO2 ratio <300 mm Hg, or arterial oxyhemoglobin saturation measured by pulse oximetry <90% and requiring oxygen therapy),
7. Respiratory failure (postoperative PaO2 <60 mm Hg on room air, PaO2/FiO2 ratio <300 mm Hg, or arterial oxyhemoglobin saturation measured by pulse oximetry <90% and requiring oxygen therapy),
8. Atelectasis (pulmonary opacification with mediastinal mediastinal displacement, displacement of the hilum or hemidiaphragm towards the affected area, with compensatory hyperinflation in the adjacent lung)
9. Bronchospasm (expiratory wheezing) newly detected and treated with bronchodilators)
10. Duration of mechanical ventilation in hours between arrival to orotracheal extubation
11. Lung Injury (sRAGE essay)
12. Cumulative consumption of morphine or oxycodone over 48 hours, expressed in milligrams
13. Length of stay defined in days between admission to hospital discharge.
14. Chronic pain will be assessed at month 2 using the QCD questionnaire (short pain questionnaire)

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire Amiens Picardie

Sponsor organisation

Centre Hospitalier Universitaire Amiens Picardie

Address

1 Rond Point Du Pr Christian Cabrol

City

Amiens Cedex 1

Postcode

80054

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire Amiens Picardie

Contact name

Pierre HUETTE

Public contact point

Organisation

Centre Hospitalier Universitaire Amiens Picardie

Contact name

Pierre HUETTE

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Application history

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