Evaluating local anesthetics for pain relief after heart surgery

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

This study tests if using local anesthetics during heart surgery can help adults with certain breathing issues feel less pain and recover faster than using regular pain medications.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 114 (estimated)
• Ages: 75 Years and up
• Sex: All
• Sponsor: CHU de Reims (other)
• Locations: 1 site (Reims)
• Trial ID: NCT06463899 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of administering local anesthetics through two catheters placed during coronary bypass surgery to improve postoperative pain management. The focus is on assessing how this approach impacts respiratory function and recovery time compared to traditional intravenous analgesics. By reducing reliance on opioids and minimizing their adverse effects, the study aims to enhance patient rehabilitation and decrease the length of hospital stays. The study targets adults with specific respiratory risk factors who are undergoing on-pump coronary bypass surgery.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old requiring on-pump coronary bypass surgery with specific respiratory risk factors.

Not a fit: Patients undergoing emergency surgery or those with severe preoperative conditions such as renal failure or pulmonary arterial hypertension may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to faster recovery times and reduced hospital stays for patients undergoing coronary bypass surgery.

How similar studies have performed: Other studies have shown promising results with similar multimodal analgesia approaches, suggesting potential for success in this study.

Eligibility criteria

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* Active or withdrawn smoking for less than 6 weeks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 excluded from the protocol.

Where this trial is running

Reims

• Damien JOLLY — Reims, France (RECRUITING)

Study contacts

• Study coordinator: Salvadore MUCCIO

Conditions: Duration of Hospitalization in Intensive Care Unit, para-sternal catheters, analgesia, coronary bypass surgery, sternotomy, hospitalization