Ignite Creation Date:
2024-07-17 @ 11:01 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06463899
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2023-08-14
Brief 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
Sponsor:
CHU de Reims
Organization:
CHU de Reims
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PARALSTER
Brief 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
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
Detailed Description:
Medical context
Cardiac surgery and more specifically coronary bypass surgery are very painful postoperative surgeries especially during the first 48 hours following the operation These pains present at rest are increased when the patient is mobilized during coughing deep inspiration chairing or mobilization in bed
In cardiac surgery it has been shown that respiratory complications remain a significant cause of morbidity and mortality They can lead to an extension of the length of hospitalization and therefore an increase in hospital costs Indeed these are increased compared to other surgeries because of the sternotomy and the pain it causes as well as the type of ventilation during extracorporeal circulation sharp reduction or even stopping of mechanical ventilation
Patients having prior to surgery risk factors for postoperative respiratory complications present increased risks of pneumonia postoperative atelectasis pleurisy re-intubation mortality and therefore an additional cost of hospitalization
Limiting postoperative pain allows better rehabilitation of the patient by improving patient mobilization participation in respiratory physiotherapy and therefore potentially a reduction in respiratory complications
Currently multimodal analgesia combining opioids nefopam nonsteroidal anti-inflammatory drugs ketamine lidocaine and paracetamol is the most widely used technique in patients The analgesic efficacy provided by opioids is tempered by their side effects sedation confusion nausea or vomiting transit delay urinary retention pruritus which may slow postoperative recovery In addition opioids can also decrease the cough reflex and impair respiratory control
It is therefore important to find alternatives to the analgesic management of these patients who thanks to the improvement of surgical and anesthetic techniques are more and more numerous
The use of para-sternal catheters with bilateral infusion of local anesthetics has already shown its effectiveness in terms of reducing opioid consumption and safety However no benefit has yet been proven in terms of reducing the length of hospital stay in subjects at respiratory risk undergoing surgery such as on pump coronary bypass surgery
Goal
Show that the use of a bilateral para-sternal infusion of local anesthetics ropivacaine 02 by multi-perforated catheters in patients with respiratory risk factors who have undergone coronary bypass surgery makes it possible to reduce the length of stay in an intensive care unit
Cardiac surgery and more specifically coronary bypass surgery are very painful postoperative surgeries especially during the first 48 hours following the operation These pains present at rest are increased when the patient is mobilized during coughing deep inspiration chairing or mobilization in bed
In cardiac surgery it has been shown that respiratory complications remain a significant cause of morbidity and mortality They can lead to an extension of the length of hospitalization and therefore an increase in hospital costs Indeed these are increased compared to other surgeries because of the sternotomy and the pain it causes as well as the type of ventilation during extracorporeal circulation sharp reduction or even stopping of mechanical ventilation
Patients having prior to surgery risk factors for postoperative respiratory complications present increased risks of pneumonia postoperative atelectasis pleurisy re-intubation mortality and therefore an additional cost of hospitalization
Limiting postoperative pain allows better rehabilitation of the patient by improving patient mobilization participation in respiratory physiotherapy and therefore potentially a reduction in respiratory complications
Currently multimodal analgesia combining opioids nefopam nonsteroidal anti-inflammatory drugs ketamine lidocaine and paracetamol is the most widely used technique in patients The analgesic efficacy provided by opioids is tempered by their side effects sedation confusion nausea or vomiting transit delay urinary retention pruritus which may slow postoperative recovery In addition opioids can also decrease the cough reflex and impair respiratory control
It is therefore important to find alternatives to the analgesic management of these patients who thanks to the improvement of surgical and anesthetic techniques are more and more numerous
The use of para-sternal catheters with bilateral infusion of local anesthetics has already shown its effectiveness in terms of reducing opioid consumption and safety However no benefit has yet been proven in terms of reducing the length of hospital stay in subjects at respiratory risk undergoing surgery such as on pump coronary bypass surgery
Goal
Show that the use of a bilateral para-sternal infusion of local anesthetics ropivacaine 02 by multi-perforated catheters in patients with respiratory risk factors who have undergone coronary bypass surgery makes it possible to reduce the length of stay in an intensive care unit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None