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Scheduled Cardiac SurgeryPhase 2Pre-BLS-SternoNCT04495504

Administration of Ropivacaine by Bi-laterosternal Multiperforated Catheters Placed Before a Sternotomy for Cardiac Surgery

A Phase 2 study testing Ropivacaine in people with Scheduled Cardiac Surgery and Age Under 85 Years, run by University Hospital, Clermont-Ferrand at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The sternotomy site is the most painful site after cardiac surgery. Local infiltration of ropivacaine through the multihole catheters in the bilaterosternal position (BLS) after sternotomy significantly reduces pain at rest and during mobilization, reduces opioids consumption, decreases postoperative complications… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Scheduled Cardiac Surgery, Age Under 85 Years
What is being tested?
Ropivacaine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteFrance
Study dates
22 Jul 2020to 12 Jul 2021
Phase
Phase 2
Are there results?
None posted in the registry

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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who undergo scheduled cardiac surgery with sternotomy: aortic or mitral valve replacement, biological or mechanical, coronary bypass surgery
  • Age under 85 years
  • Patients who have given their consent according to the methods described in Title II of the book of the first Public Health Code
  • Possession of Social Security insurance.

Who cannot join

  • Emergency surgery
  • Approach by thoracotomy
  • Heart transplant
  • Aortic dissection
  • Redo surgery.
  • Pregnant women
Show all 16Show fewer
  • Refusal of the protocol
  • Protected minors or adults
  • Pre-existing psychiatric pathology including known states of opioid addiction
  • Long-term opioid medication
  • Physical or intellectual inability to use a PCA
  • Severe heart failure (ejection fraction less than 40% or PAH > 50 mmHg)
  • Preoperative cardiogenic shock
  • Severe preoperative chronic or acute renal failure with a creatinine clearance of less than 30 mL / min according to Cockroft's formula
  • Known hypersensitivity to local anesthetics or to any component of the catheter
  • Known allergy or hypersensitivity to any of the study drugs or analgesia protocol (ropivacaine, paracetamol, opiates).

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU Clermont-Ferrand - Service de Chirurgie Cardio-Vasculaire

    Clermont-Ferrand, Puy de Dôme, 63000

Other trials in France

About this study

Official title: The Effect of Continuous Administration of Ropivacaine by Bi-laterosternal Multiperforated Catheters Placed Before a Sternotomy for Cardiac Surgery

The sternotomy site is the most painful site after cardiac surgery. Local infiltration of ropivacaine through the multihole catheters in the bilaterosternal position (BLS) after sternotomy significantly reduces pain at rest and during mobilization, reduces opioids consumption, decreases postoperative complications, improves patient comfort and satisfaction and reduced hospital costs. In this study our hypothesis is to test the efficacity of local anesthetic administration via the catheters in the BLS position placed before the surgical incision.

Read the detailed description

Goal of the study: Evaluation of the effectiveness of BLS technique on a composite endpoint (pain at rest, pain during patient mobilization and opioid consumption).

Open trial, therapeutic, prospective, monocentric. One group of patients who will benefits from the placement of two multihole catheters in BLS position:

  • The ropivacaine group (40 patients): placement by the surgeon of two catheters in BLS position before the surgical incision. Administration of a bolus dose of 10 ml of ropivacaine 7, 5 mg/mL in each catheter followed by a continuous infusion of ropivacaine 2 mg/ml in a rate of 3 mL/h during the first 48 hours postoperatively.
  • The control group (80 patients) from the two previous studies who underwent standard analgesia with PCA morphine.
Being tested
Ropivacaine
Keywords
Postoperative analgesia, Sternotomy, Local anesthetics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RopivacaineDrug

    Administration of a bolus dose of 10 ml of ropivacaine 7, 5 mg/mL in each catheter Continuous infusion of ropivacaine 2 mg/ml in a rate of 3 mL/h during the first 48 hours postoperatively.

Study groups in NCT04495504
Study groupRoleWhat they receive
Ropivacaine groupExperimentalAdministration of a bolus dose of ropivacaine, followed by a continuous infusion of ropivacaine during the first 48 hours postoperatively.
Receives: Drug: Ropivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain evaluation

    The technique is considered as a fail if : pain rest > 3.5 /10 (0 = no pain; 10 maximum pain) or pain during mobilization > 3.5/10 (0 = no pain; 10 maximum pain)

    Measured: Day 2 postoperatively.

  2. Opioid consumption

    The technique is considered as a fail if morphine consumption > 35 mg

    Measured: Day 2 postoperatively.

Secondary outcomes (10)

  1. ICU length of stay

    Days of ICU and hospital stay

    Measured: Up to 6 months

  2. Hospital length of stay

    Days of ICU and hospital stay

    Measured: Up to 6 months

  3. Patient satisfaction

    Patient satisfaction evaluation from the patient based on a simple Likert scale:

    0 = very bad; 1 = bad; 2 = medium; 3 = good; 4 = excellent.

    Measured: Day 2 postoperatively.

  4. Postoperative nausea and vomiting

    assessed by the Wengritzky intensity scale (if total score > 50, the nausea and vomiting are clincally significant)

    Measured: Day 1 and 2 postoperatively.

  5. Respiratory complications

    Occurrence of postoperative respiratory complications

    Measured: Up to 6 months

  6. Cardiac complications

    Occurrence of postoperative cardiac complications

    Measured: Up to 6 months

  7. Neurological complications

    Occurrence of postoperative neurological complications

    Measured: Up to 6 months

  8. Renal,complications

    Occurrence of postoperative renal complications

    Measured: Up to 6 months

  9. Infectious complications

    Occurrence of postoperative infectious complications

    Measured: Up to 6 months

  10. Chronic pain evaluation

    Chronic pain assessed at the 6th postoperative month by DN4 (Neuropathic Pain Diagnostic 4) score

    Measured: Assessed at the 6th postoperative month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2020
  2. Study start22 Jul 2020
  3. Primary completion12 Jan 2021
  4. Study completion12 Jul 2021

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Placement by the surgeon of two catheters in BLS position before the surgical incision. Administration of a bolus dose of 10 ml of ropivacaine 7, 5 mg/mL in each catheter followed by a continuous infusion of ropivacaine 2 mg/ml in a rate of 3 mL/h during the first 48 hours postoperatively.
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04495504
Sponsor's protocol ID
Pré-BLS-Sterno-RBHP 2018 ELJEZ
Acronym
Pre-BLS-Sterno
Status last verified
Aug 2026
First submitted
23 Jul 2020
Last updated
7 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Eljezi V, Jallas C, Pereira B, Chasteloux M, Duale C, Camilleri L. Clinical Benefits of Parasternal Block with Multihole Catheters when Inserted before Sternotomy. Ann Card Anaesth. 2025 Jan 1;28(1):39-45. doi: 10.4103/aca.aca_110_24. Epub 2024 Nov 19.

    PubMed 39774178

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ropivacaine in people with Scheduled Cardiac Surgery and Age Under 85 Years, run by University Hospital, Clermont-Ferrand 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 4 inclusion and 16 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: finished, as of the sponsor's last update on 7 Aug 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Pain evaluation (time frame: Day 2 postoperatively.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04495504, which also lists 1 linked publication.

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 7 Aug 2026.

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