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

Not Applicable

Recruiting

• Conditions: Duration of Hospitalization in Intensive Care Unit

• Registration Number: NCT06463899
• Lead Sponsor: CHU de Reims

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.

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 0.2%) 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 Timeline

• Study Start: 2023-02-08
• Study First Submitted: 2023-08-14
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-14
• Study First Posted: 2024-06-18
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-13
• Primary Completion: 2025-11-08
• Study Completion: 2026-02-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evaluation of the duration of hospitalization in intensive care unit	Day 1	Study of the benefit of the administration of local anesthetics via two catheters placed during surgery on recovery time versus currently intravenous analgesics that are used for postoperative analgesia, which are tempered by their adverse effects, and can slow down postoperative recovery.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the pain at rest and on mobilization using a visual pain evaluation scale	Day 2	Study of the effectiveness of the administration of local anesthetics via two catheters placed during surgery, including their benefit on respiratory function, versus currently intravenous analgesics that are used for postoperative analgesia, which are tempered by their adverse effects.
Evaluation of the total consumption of opioids	At 48 hours	Study of the use of local anesthetics via two catheters placed during surgery for morphine sparing versus the use of currently intravenous analgesics that are used for postoperative analgesia which are multimodal analgesia combining opioids like nefopam, nonsteroidal anti-inflammatory drugs, ketamine, lidocaine and paracetamol
Evaluation of the patient mortality	Day 30	Study of the benefit of the administration of local anesthetics via two catheters placed during surgery on respiratory function and complications which remains a significant cause of morbidity and mortality versus currently intravenous analgesics that are used for postoperative analgesia, which are tempered by their adverse effects.
Evaluation of the occurrence of the side effects of opioids	At 48 hours	Study of the benefit of the administration of local anesthetics via two catheters placed during surgery versus currently intravenous analgesics that are used for postoperative analgesia, which are tempered by their adverse effects as sedation, confusion, nausea or vomiting, delayed transit, urinary retention and pruritus.

Trial Locations

Locations (1)

Damien JOLLY; 🇫🇷 Reims, France