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RECRUITING
NCT07116343
PHASE4

Intrapleural Ropivacaine Infusion in Cardiac Surgery

Sponsor: Saint Petersburg State University, Russia

View on ClinicalTrials.gov

Summary

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.

Official title: Intrapleural Ropivacaine Infusion in Cardiac Surgery: Randomized Double-blind Controlled Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

116

Start Date

2025-10-22

Completion Date

2027-12-01

Last Updated

2026-03-10

Healthy Volunteers

No

Interventions

DRUG

Ropivacaine

The patient will receive 0.2% ropivacaine (20.0 ml) into the pleural cavity intraoperatively before sternal closure. A continuous infusion of 0.2% ropivacaine will be administered through a microcatheter into the drained pleural cavity, with titration of the infusion rate. The initial infusion rate is set at 10 ml/hour.

DRUG

0.9 % NaCl

The patient will receive 20.0 ml of a 0.9% sodium chloride solution into the pleural cavity intraoperatively, prior to sternal closure. A continuous infusion of 0.9% sodium chloride solution will then be administered through a microcatheter into the drained pleural cavity. The initial infusion rate is set at 10 ml/hour.

Locations (2)

Saint-Petersburg university hospital

Saint Petersburg, Russia

Primorskiy general hospital #1

Vladivostok, Russia