Intrapleural Ropivacaine Infusion in Cardiac Surgery

NCT07116343 | Recruiting Phase 4

• 1 other identifier: SPBU IRICS study
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cardiac Surgery; Coronary Artery Disease; Valvular Diseases

Keywords

cardiac surgery; quality of recovery; ropivacaine; postoperative analgesia

Outcome Measures

Primary Outcomes (1)

• Quality of recovery after anesthesia (QoR15) questionnaire

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

  24 hours after surgery

Secondary Outcomes (3)

• pO2/FiO2 ratio

  6, 12, 24 hours after surgery

• Morphine equvalents, mg/day

  24 hours after surgery

• Pain assessed by Visual analog scale

  6, 12, 24, 48 hours

Other Outcomes (4)

• Postoperative complications

  at discharge (assessed up to 30 days)

• Hospital mortality

  At discharge (assessed up to 6 months)

• Length of hospitalisation

  At discharge (assessed up to 6 months)

Study Arms (2)

Intrapleural ropivacaine

EXPERIMENTAL

Drug: Ropivacaine

Intrapleural placebo

PLACEBO COMPARATOR

Drug: 0.9 % NaCl

Interventions

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.

Intrapleural ropivacaine

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.

Intrapleural placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Contraindications for ropivacaine
• Redo surgery

Sponsors & Collaborators

• Saint Petersburg State University, Russia: lead
• Primorsky Regional Clinical Hospital No. 1: collaborator

Study Sites (2)

Saint-Petersburg university hospital

Saint Petersburg, Russia

RECRUITING

Primorskiy general hospital #1

Vladivostok, Russia

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Ropivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Sergey M Efremov, MD, PhD

CONTACT

79137946090; efremovsergm@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director for science, Saint-Petersburg state university hospital

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 11, 2025
• Study Start: October 22, 2025
• Primary Completion (Estimated): September 25, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

RU (2)