Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07116343

Intrapleural Ropivacaine Infusion in Cardiac Surgery

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Saint-Petersburg university hospital, Saint Petersburg, Russia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine

Drug

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.

0.9 % NaCl

Drug

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.

Primary outcomes

  1. Quality of recovery after anesthesia (QoR15) questionnaire

    Time frame: 24 hours after surgery

    ranged from 0 to 150 points, where 0 is the worst and 150 is the best.

Secondary outcomes

  1. pO2/FiO2 ratio

    Time frame: 6, 12, 24 hours after surgery

  2. Morphine equvalents, mg/day

    Time frame: 24 hours after surgery

  3. Pain assessed by Visual analog scale

    Time frame: 6, 12, 24, 48 hours

    from 0 to 10 when 0 is worst and 10 is best

Other outcomes

  1. Postoperative complications

    Time frame: at discharge (assessed up to 30 days)

    Composite (myocardial infarction, stroke, delirium, new onset atrial fibrillation, infections)

  2. Hospital mortality

    Time frame: At discharge (assessed up to 6 months)

    Death during hospitalisation

  3. Length of hospitalisation

    Time frame: At discharge (assessed up to 6 months)

    Number of days in hospital during initial hospitalisation

  4. Sternal wound dehiscence

    Time frame: At discharge (assessed up to 6 months)

Study contacts

Contact information is provided by the study sponsor or research team.

Sergey M Efremov, MD, PhD

CONTACT

[email protected]

79137946090

Sponsors and collaborators

Lead sponsor

Saint Petersburg State University, Russia

Other

Collaborators

  • Primorsky Regional Clinical Hospital No. 1

Registry information

Official study title

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

Acronym: IRICS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 11, 2025
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.