RecruitingNot ApplicableNCT06463899

Evaluation of the Effectiveness of the Administration of Local Anesthetics Via Two Catheters Placed During Surgery, and Study of the Benefits on Respiratory Function and Therefore on Recovery Time

Impact of Bilateral Parasternal Infusion of Local Anesthetics in Patients With Respiratory Risk Factors Over the Length of Hospitalization and Morphine Sparing in the Intensive Care Unit After On-pump Coronary Bypass Surgery


Sponsor

CHU de Reims

Enrollment

114 participants

Start Date

Feb 8, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Currently intravenous analgesics are used for postoperative analgesia. But the analgesia of these products is tempered by their adverse effects (sedation, confusion, nausea or vomiting, delayed transit, urinary retention and pruritus) which can slow down postoperative recovery. The aim of this study is to evaluate the effectiveness of the administration of local anesthetics via two catheters placed during surgery, but also to study their benefit on respiratory function and therefore on recovery time and morphine sparing.


Eligibility

Min Age: 75 Years

Inclusion Criteria6

  • This study will include adults over 18 years of age requiring on-pump coronary bypass surgery with at least one of the following respiratory risk factors:
  • BMI \> or = 30 Kg / m2
  • Active or withdrawn smoking for less than 6 weeks
  • COPD documented by pulmonologist or respiratory function test (LVEF/ FVC \<0.7 not reversible after bronchodilator)
  • Restrictive ventilatory disorders, defined by a CPT less than 80% of normal
  • Chronic respiratory failure, defined by a PaO2, at rest, in ambient air, less than 70 mmHg

Exclusion Criteria16

  • Any patient meeting one of the following criteria will be excluded from the study:
  • Emergency surgery
  • Other operative procedure planned during the same intervention (for example vascular), apart from the saphenous sample
  • Aortic dissection
  • Preoperative renal failure with GFR \<30 mL / min / 1.73 m2
  • Left heart failure with Ejection fraction \<30%
  • Pulmonary arterial hypertension\> 50 mmHg
  • Hepatic cytolysis with ALT or AST\> 2N
  • ASA score \> or = 4
  • Coagulopathy
  • Anticoagulants or antiaggregants not stopped in time (according to usual protocols) or with poorly performed or unjustified relay
  • Chronic use of opioids or history of drug addiction
  • Progressive pregnancy or breastfeeding
  • Inability to understand protocol and sign consent
  • Known allergy to one of the substances in the study protocol
  • Patients requiring assistance such as ECMO, intra-aortic counter pulsation balloon or Impella will be excluded from the protocol.

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Interventions

PROCEDUREmulti-perforated catheter

After skin closure, cardiac surgeons place multi-perforated catheters aseptically.

PROCEDUREClassic procedure

opioid analgesia (PCA morphine in bolus mode alone or morphine titration if PCA not available), nefopam, non-steroidal anti-inflammatory drugs, ketamine, pregabalin and paracetamol


Locations(1)

Damien JOLLY

Reims, France

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NCT06463899