RecruitingN/AOther

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

Sponsored by CHU de Reims

NCT ID
NCT06463899
Target Enrollment
114 participants
Start Date
2023-02-08
Est. Completion
2026-02-08

About This Study

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.

Conditions Studied

Duration of Hospitalization in Intensive Care Unit

Interventions

  • multi-perforated catheter
  • Classic procedure

Eligibility

Age:75 Years - N/A
Healthy Volunteers:No
View full eligibility criteria
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* Active or withdrawn smoking for less than 6 weeks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
* Age \> or = 75 years old exclusion criteria:

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.

Study Locations (1)

Damien JOLLY
Reims, France

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

Salvadore MUCCIO
CONTACT
03 10 73 66 50smuccio@chu-reims.fr
View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

Last updated from source

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