Evaluation of the Effectiveness of the Administration of Local Anesthetics Via Two Catheters Plac… (NCT06463899) | Clinical Trial Compass
RecruitingNot Applicable
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
France114 participantsStarted 2023-02-08
Plain-language 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.
Who can participate
Age range
75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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* Active or withdrawn smoking for less than 6 weeks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 exclu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation of the duration of hospitalization in intensive care unit