Intrapleural Ropivacaine Infusion in Cardiac Surgery

Not Applicable

Not yet recruiting

• Conditions: Cardiac Surgery; Coronary Artery Disease; Valvular Diseases
• Interventions: Drug: Ropivacaine; Drug: 0.9 % NaCl

• Registration Number: NCT07116343
• Lead Sponsor: Saint Petersburg State University, Russia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-29
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-08
• Last Update Submitted: 2025-08-08
• Study First Posted: 2025-08-11
• Last Update Posted: 2025-08-11
• Study Start: 2025-09-25
• Primary Completion: 2027-09-25
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 116

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intrapleural ropivacaine	Ropivacaine	-
Intrapleural placebo	0.9 % NaCl	-

Primary Outcome Measures

Name	Time	Method
Quality of recovery after anesthesia (QoR15) questionnaire	24 hours after surgery	ranged from 0 to 150 points, where 0 is the worst and 150 is the best.

Secondary Outcome Measures

Name	Time	Method
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	from 0 to 10 when 0 is worst and 10 is best