Intrapleural Ropivacaine Infusion in Cardiac Surgery (IRICS)

Saint Petersburg State University, Russia

Status and phase: Enrolling; Phase 4

Conditions: Coronary Artery Disease; Cardiac Surgery; Valvular Diseases

Treatments: Drug: 0.9 % NaCl; Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT07116343

SPBU IRICS study

Details and patient eligibility

About

For many patients, a primary source of postoperative pain following cardiac surgery is the presence of pleural drains, which the surgeon places at the end of the operation and maintains for 1 to 3 days. One promising method of pain management after cardiac surgery is interpleural analgesia, particularly when traditional analgesic methods, such as systemic opioids or epidural anesthesia, may be limited due to the risk of complications. Interpleural analgesia involves the introduction of local anesthetics directly into the pleural cavity through drainage tubes placed after cardiac surgery. This method targets pain receptors in the chest area, providing effective analgesia without significant systemic effects. Several clinical studies have confirmed the safety and efficacy of intrapleural administration of anesthetics after thoracic surgery. The aim of this randomised double-blind placebo controlled study is to test the hypothesis that, in patients after cardiac surgery, the quality of recovery from anesthesia with intrapleural use of ropivacaine is superior to that with a placebo.

Enrollment: 116 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Scheduled cardiac surgery using a standard median sternotomy.
• Planned opening of the pleural cavities.
• Age more than 18 years.
• Signed informed consent to participate in the study.

Exclusion criteria

• Contraindications for ropivacaine
• Redo surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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116 participants in 2 patient groups, including a placebo group

Intrapleural ropivacaine

Experimental group

Treatment:

Drug: Ropivacaine

Intrapleural placebo

Placebo Comparator group

Treatment:

Drug: 0.9 % NaCl