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

NCT ID: NCT06463899

Last Updated: 2024-11-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-08
• Study Completion Date: 2026-02-08

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.

Conditions

Duration of Hospitalization in Intensive Care Unit

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

WITH catheter

A "multi-perforated catheter" arm benefiting from opioid analgesia (Patient controlled Analgesia ((PCA)) morphine (bolus-only mode or morphine titration if PCA not available), nefopam, non-steroidal anti-inflammatory drugs, ketamine, pregabalin and paracetamol associated with analgesia by continuous infusion of local anesthetics (ropivacaine) via two multi-perforated catheters

Group Type: EXPERIMENTAL

multi-perforated catheter

Intervention Type: PROCEDURE

After skin closure, cardiac surgeons place multi-perforated catheters aseptically.

WITHOUT catheter

A "control" arm benefiting from opioid analgesia (PCA morphine in bolus mode alone or morphine titration if PCA not available), nefopam, non-steroidal anti-inflammatory drugs, ketamine, pregabalin and paracetamol.

Group Type: ACTIVE_COMPARATOR

Classic procedure

Intervention Type: PROCEDURE

opioid analgesia (PCA morphine in bolus mode alone or morphine titration if PCA not available), nefopam, non-steroidal anti-inflammatory drugs, ketamine, pregabalin and paracetamol

Interventions

multi-perforated catheter

After skin closure, cardiac surgeons place multi-perforated catheters aseptically.

Intervention Type: PROCEDURE

Classic procedure

opioid analgesia (PCA morphine in bolus mode alone or morphine titration if PCA not available), nefopam, non-steroidal anti-inflammatory drugs, ketamine, pregabalin and paracetamol

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CHU de Reims

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Damien JOLLY

Reims, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Salvadore MUCCIO

Role: CONTACT

smuccio@chu-reims.fr

03 10 73 66 50 ext. 0033

Facility Contacts

Salvadore MUCCIO

Role: primary

smuccio@chu-reims.fr

03 10 73 66 50 ext. 0033

Other Identifiers

PO22011

Identifier Type: -

Identifier Source: org_study_id