Cardiac SurgeryPhase 3PARACARDNCT05515809
Evaluation of the Effect of Para-sternal Block on Postoperative Respiratory Function After Cardiac Sternotomy Surgery
A Phase 3 study testing parasternal block and Standard pain management in people with Cardiac Surgery and Ultrasound-guided Parasternal Block, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Postoperative pain after cardiac surgery is associated with reduced postoperative respiratory function. There is an association between greater pain and more pronounced decreases in lung volumes postoperatively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery, Ultrasound-guided Parasternal Block, Postoperative Pulmonary Complications
- What is being tested?
- parasternal block and Standard pain management
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jul 2022to Jun 2025
- Phase
- Phase 3
- 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
- Patients over 18 years of age
- Elective cardiac surgery under CEC with sternotomy
- Written informed consent from the patient.
- Women of childbearing age must have a negative urine HCG pregnancy test.
- Pregnancy
Who cannot join
- Thoracotomy approach
- Mini-sternotomy approach
- Opioid drug dependence or chronic opioid drug use
- Chronic benzodiazepine use (respiratory depressant treatment or treatment that may affect postoperative respiratory function)
- Contraindication or allergy to local anesthetics
- Emergency surgery
Show all 11Show fewer
- Acute infective endocarditis
- Immunosuppressive or steroid treatment (prednisone > 0.5mg/kg/day or equivalent)
- AIDS with CD4 count <200/mm3
- Autoimmune disorder
- Transplant recipient
Trial locations and contacts
1 site in 1 country.
About this study
Postoperative pain after cardiac surgery is associated with reduced postoperative respiratory function. There is an association between greater pain and more pronounced decreases in lung volumes postoperatively. With an incidence of 10% to 25% of cases, pulmonary complications are the second source of postoperative morbidity after cardiac complications; in 2-5% of cases, the dysfunction is severe and leads to significant consequences that can lead to death. It has been shown that postoperative pain after cardiac surgery is associated with a reduction in functional respiratory capacity. There is an association between greater pain and more pronounced decreases in lung volumes postoperatively. The main objective of this study will be to evaluate the impact of locoregional anesthesia by parasternal block analgesic on postoperative respiratory function at D1 postoperatively
- Conditions
- Cardiac Surgery, Ultrasound-guided Parasternal Block, Postoperative Pulmonary Complications, Pulmonary Function Testing
- Being tested
- parasternal block, Standard pain management
- Keywords
- Cardiac surgery, Ultrasound-guided Parasternal Block, Postoperative pulmonary complications, Pulmonary function testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parasternal blockDrug
Echo-guided loco-regional anesthesia by bilateral parasternal block in immediate preoperative.
The drug used is Ropivacaine 2mg/ml, 0.2%. Injection of 20ml per side, under ultrasound control, after general anaesthesia and before skin incision, and therefore before surgery
Standard pain managementDrug
Standard pain management care involves a multimodal strategy that includes the use of intravenous analgesics. Morphine medications are the mainstay of pain management
| Study group | Role | What they receive |
|---|---|---|
| interventional arm | Experimental | the experimental arm will receive the parasternal block with injection of locoregional anesthesia Receives: Drug: parasternal block |
| control arm not requiring loco-regional anesthesia. | Active comparator | the control arm will receive a standard treatment, without locoregional anesthesia Receives: Drug: Standard pain management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in postoperative forced vital capacity (FVC)
The primary endpoint was the change (reduction) in postoperative forced vital capacity (FVC) between the preoperative measurement and at D1 postoperatively.
- "Forced Vital Capacity measured by SPIROLAB spirometry (Appendix).
- "Vital capacity is expressed as % of theoretical value.
Measured: 1 day
Secondary outcomes (4)
Variation of FCV between both groups
Respiratory functional investigations at day 2 is forced vital capacity (FVC)
Measured: at day 2
Variation of FCV between both groups
Respiratory functional investigations at 1 month is forced vital capacity (FVC)
Measured: at 1 month
Variation of FCV between both groups
Respiratory functional investigations at 3 months is forced vital capacity (FVC)
Measured: at 3 months
Variation of forced expiratory volume in 1 second (FEV1)
Respiratory functional investigations at day 2 are forced expiratory volume in 1 second (FEV1)
Measured: at day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start19 Jul 2022
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (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.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515809
- Sponsor's protocol ID
- PI2021_843_0229
- Acronym
- PARACARD
- Status last verified
- May 2025
- First submitted
- 28 Jul 2022
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Para-sternal Block on Postoperative Respiratory Function After Cardiac Sternotomy Surgery
- ClinicalTrials.gov ID
- NCT05515809
- Acronym / sponsor ID
- PARACARD / PI2021_843_0229
- Conditions
- Cardiac Surgery, Ultrasound-guided Parasternal Block, Postoperative Pulmonary Complications, Pulmonary Function Testing
- Keywords
- Cardiac surgery, Ultrasound-guided Parasternal Block, Postoperative pulmonary complications, Pulmonary function testing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 19 Jul 2022 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 25 Aug 2022 (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.
Postoperative pain after cardiac surgery is associated with reduced postoperative respiratory function. There is an association between greater pain and more pronounced decreases in lung volumes postoperatively. With an incidence of 10% to 25% of cases, pulmonary complications are the second source of postoperative morbidity after cardiac complications; in 2-5% of cases, the dysfunction is severe and leads to significant consequences that can lead to death. It has been shown that postoperative pain after cardiac surgery is associated with a reduction in functional respiratory capacity. There is an association between greater pain and more pronounced decreases in lung volumes postoperatively. The main objective of this study will be to evaluate the impact of locoregional anesthesia by parasternal block analgesic on postoperative respiratory function at D1 postoperatively
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interventional arm | Experimental | Drug: parasternal blockthe experimental arm will receive the parasternal block with injection of locoregional anesthesia |
| control arm not requiring loco-regional anesthesia. | Active comparator | Drug: Standard pain managementthe control arm will receive a standard treatment, without locoregional anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients over 18 years of age
- Elective cardiac surgery under CEC with sternotomy
- Written informed consent from the patient.
- Women of childbearing age must have a negative urine HCG pregnancy test.
- Pregnancy
Key exclusion criteria (11 listed)
- Thoracotomy approach
- Mini-sternotomy approach
- Opioid drug dependence or chronic opioid drug use
- Chronic benzodiazepine use (respiratory depressant treatment or treatment that may affect postoperative respiratory function)
- Contraindication or allergy to local anesthetics
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 |
|---|---|---|
| parasternal blockEcho-guided loco-regional anesthesia by bilateral parasternal block in immediate preoperative. The drug used is Ropivacaine 2mg/ml, 0.2%. Injection of 20ml per side, under ultrasound control, after general anaesthesia and before skin incision, and therefore before surgery | Drug | interventional arm |
| Standard pain managementStandard pain management care involves a multimodal strategy that includes the use of intravenous analgesics. Morphine medications are the mainstay of pain management | Drug | control arm not requiring loco-regional anesthesia. |
Primary outcome
Change in postoperative forced vital capacity (FVC)
Time frame: 1 day
The primary endpoint was the change (reduction) in postoperative forced vital capacity (FVC) between the preoperative measurement and at D1 postoperatively. * "Forced Vital Capacity measured by SPIROLAB spirometry (Appendix). * "Vital capacity is expressed as % of theoretical value.
4 secondary outcomes
Variation of FCV between both groups
Time frame: at day 2
Variation of FCV between both groups
Time frame: at 1 month
Variation of FCV between both groups
Time frame: at 3 months
Variation of forced expiratory volume in 1 second (FEV1)
Time frame: at day 2
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 28 May 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing parasternal block and Standard pain management in people with Cardiac Surgery and Ultrasound-guided Parasternal Block, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 5 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in postoperative forced vital capacity (FVC) (time frame: 1 day). 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 28 May 2025.