Cardiac SurgeryPhase 4IRICSNCT07116343
Intrapleural Ropivacaine Infusion in Cardiac Surgery
A Phase 4 study testing Ropivacaine and 0.9 % NaCl in people with Cardiac Surgery and Coronary Artery Disease, run by Saint Petersburg State University, Russia at 2 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery, Coronary Artery Disease, Valvular Diseases
- What is being tested?
- Ropivacaine and 0.9 % NaCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 2 sitesRussia
- Study dates
- 22 Oct 2025to 1 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Contraindications for ropivacaine
- Redo surgery
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Russia2 sites, 2 recruiting
- Recruiting
Saint-Petersburg university hospital
Saint Petersburg
Sergey Efremov
- Recruiting
Primorskiy general hospital #1
Vladivostok
Evgenii Kokarev
About this study
Official title: Intrapleural Ropivacaine Infusion in Cardiac Surgery: Randomized Double-blind Controlled Study
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
- Being tested
- Ropivacaine, 0.9 % NaCl
- Keywords
- cardiac surgery, quality of recovery, ropivacaine, postoperative analgesia
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
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 % NaClDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Intrapleural ropivacaine | Experimental | Not described Receives: Drug: Ropivacaine |
| Intrapleural placebo | Placebo comparator | Not described Receives: Drug: 0.9 % NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of recovery after anesthesia (QoR15) questionnaire
ranged from 0 to 150 points, where 0 is the worst and 150 is the best.
Measured: 24 hours after surgery
Secondary outcomes (3)
pO2/FiO2 ratio
Measured: 6, 12, 24 hours after surgery
Morphine equvalents, mg/day
Measured: 24 hours after surgery
Pain assessed by Visual analog scale
from 0 to 10 when 0 is worst and 10 is best
Measured: 6, 12, 24, 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start22 Oct 2025
- Primary completion25 Sep 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Petersburg State University, Russia
- Sponsor type
- University, hospital or other
- Collaborators
- Primorsky Regional Clinical Hospital No. 1
- Responsible party
- Principal investigator, Efremov Sergey, Saint Petersburg State University, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116343
- Sponsor's protocol ID
- SPBU IRICS study
- Acronym
- IRICS
- Status last verified
- Mar 2026
- First submitted
- 29 Jul 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be available by the reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrapleural Ropivacaine Infusion in Cardiac Surgery: Randomized Double-blind Controlled Study
- ClinicalTrials.gov ID
- NCT07116343
- Acronym / sponsor ID
- IRICS / SPBU IRICS study
- Conditions
- Cardiac Surgery, Coronary Artery Disease, Valvular Diseases
- Keywords
- cardiac surgery, quality of recovery, ropivacaine, postoperative analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Saint Petersburg State University, RussiaUniversity, hospital or other
- Collaborators
- Primorsky Regional Clinical Hospital No. 1
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- 25 Sep 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrapleural ropivacaine | Experimental | Drug: Ropivacaine |
| Intrapleural placebo | Placebo comparator | Drug: 0.9 % NaCl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Contraindications for ropivacaine
- Redo surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RopivacaineThe 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 | Intrapleural ropivacaine |
| 0.9 % NaClThe 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. | Drug | Intrapleural placebo |
Primary outcome
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.
3 secondary outcomes
pO2/FiO2 ratio
Time frame: 6, 12, 24 hours after surgery
Morphine equvalents, mg/day
Time frame: 24 hours after surgery
Pain assessed by Visual analog scale
Time frame: 6, 12, 24, 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: Yes. IPD will be available by the reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine and 0.9 % NaCl in people with Cardiac Surgery and Coronary Artery Disease, run by Saint Petersburg State University, Russia at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sergey M Efremov, MD, PhD (79137946090, efremovsergm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of recovery after anesthesia (QoR15) questionnaire (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.