Actively Recruiting

Phase Not Applicable
Age: 75Years +
All Genders
NCT06463899

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

Led by CHU de Reims · Updated on 2024-11-13

114

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 75Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults over 18 years old
  • Scheduled for on-pump coronary bypass surgery
  • Have at least one respiratory risk factor: BMI ≥ 30 kg/m2, active or recent smoker (less than 6 weeks), documented COPD, restrictive ventilatory disorders (CPT less than 80% normal), chronic respiratory failure (PaO2 less than 70 mmHg at rest in ambient air), or age 75 years or older
Not Eligible

You will not qualify if you...

  • Emergency surgery
  • Additional planned surgery during the same intervention (except saphenous vein sampling)
  • Aortic dissection
  • Preoperative renal failure with GFR less than 30 mL/min/1.73 m2
  • Left heart failure with ejection fraction less than 30%
  • Pulmonary arterial hypertension above 50 mmHg
  • Liver enzyme elevation with ALT or AST more than twice normal
  • ASA score 4 or higher
  • Coagulopathy
  • Anticoagulants or antiplatelet drugs not stopped correctly
  • Chronic opioid use or history of drug addiction
  • Pregnant or breastfeeding
  • Unable to understand the protocol or sign consent
  • Known allergy to study substances
  • Need for mechanical support like ECMO, intra-aortic balloon pump, or Impella

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Damien JOLLY

Reims, France

Actively Recruiting

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Research Team

S

Salvadore MUCCIO

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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