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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513301-30-00
Enrollment
84
Registered
2024-05-07
Start date
Unknown
Completion date
2024-10-31
Last updated
2024-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cardiac surgery

Brief summary

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.

Detailed description

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., 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., During the respiratory physiotherapy session, postoperative pain in the first 48 hours will be assessed using the EN, Daily postoperative pain from day 3 to day 7 will be assessed once between 8 a.m. and 12 p.m. using the EN, 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)., 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),, 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),, Atelectasis (pulmonary opacification with mediastinal mediastinal displacement, displacement of the hilum or hemidiaphragm towards the affected area, with compensatory hyperinflation in the adjacent lung), Bronchospasm (expiratory wheezing) newly detected and treated with bronchodilators), Duration of mechanical ventilation in hours between arrival to orotracheal extubation, Lung Injury (sRAGE essay), Cumulative consumption of morphine or oxycodone over 48 hours, expressed in milligrams, Length of stay defined in days between admission to hospital discharge., Chronic pain will be assessed at month 2 using the QCD questionnaire (short pain questionnaire)

Interventions

DRUGROPIVACAINE

Sponsors

Centre Hospitalier Universitaire Amiens Picardie
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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., 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., During the respiratory physiotherapy session, postoperative pain in the first 48 hours will be assessed using the EN, Daily postoperative pain from day 3 to day 7 will be assessed once between 8 a.m. and 12 p.m. using the EN, 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

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026