PneumoniaPhase 3STERNOCATNCT01648777
Catheter Outcomes With Sternotomy Cardiac Operated
A Phase 3 study testing L bupivacaine in people with Pneumonia and Cardiac Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Pneumonia occurs frequently in patients undergoing cardiac surgery and allows to increase their mortality. While chest physical therapy plays a crucial role to prevent postoperative pneumoniae, painful mobilization of the sternum after sternotomy limits chest physical therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Cardiac Surgery, Multiperforated Catheter
- What is being tested?
- L bupivacaine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,502 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2012to Jan 2015
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patient more than 18 years old
- planned cardiac surgery with sternotomy and bypass
- Informed consent written
Who cannot join
- Refusal of patient to be included in the study
- Age less than 18 years old
- Pregnancy
- Emergency
- Prolonged sedation and ventilation more than 48h00 expected in teh postoperative period
- Moribund patient
Show all 12Show fewer
- Palliative medicine
- Patient in the care of a guardian
- Preoperative pneumonia
- Patient randomized in an other randomized study
- Contraindication to L-bupivacain, morphine sulfate, paracetamol or tramadol
- Lack of national health care insurance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cicatricial Analgesia Catheters Outcome on Bronchopulmonary Infection Number With Sternotomy Cardiac Operated
Pneumonia occurs frequently in patients undergoing cardiac surgery and allows to increase their mortality. While chest physical therapy plays a crucial role to prevent postoperative pneumoniae, painful mobilization of the sternum after sternotomy limits chest physical therapy. The continuous local anesthetic infusion by multiperforated catheter decreases sternum pain. Because of this optimal pain management, early chest physical therapy could be more efficient and could contribute to decrease the rate of pneumonia.
The aim of this study is to test if management of sternotomy pain using continuous local anesthetic infusion by multiperforated catheter may contribute to decrease the rate of perioperative pneumonia.
Read the detailed description
Introduction:
Pneumonia occurs in 15 to 20% of patients undergoing cardiac surgery and allows to increase their mortality. Early non-invasive ventilation (NIV) after extubation and active and passive chest physical therapies have shown to diminish risk of respiratory failure and lowered 90-day mortality. Unfortunately, pain after cardiac surgery is mainly related to the median sternotomy. The mobilization of the sternum after sternotomy induces paroxysmal and periodical pain, sorely control by opioid treatment, regulated by the chest movements of ventilation or chest mobilization such during NIV or chest physical therapy. The continuous local anesthetic infusion by multiperforated catheter has been shown to be effective for decreasing paroxysmal sternum pain, opioid analgesic medication, length of intensive care medicine (ICU) and hospital stay. Because of this better pain management, early NIV and chest physical therapy could be more efficient and could contribute to decrease the rate of pneumonia in patients undergoing cardiac surgery with sternotomy.
Hypothesis: The aim of this study is to test if management of sternotomy pain using continuous local anesthetic infusion by multiperforated catheter may contribute to decrease the rate of perioperative pneumonia.
Primary end-point: Rate of post-operative pneumonia in hospital. Secondary end-points: post operative quality of Analgesia (total morphine consumption), 30-days all-cause mortality, mechanical ventilation free days, ICU free days, hospital stay, rate of ICU readmission, reintubation rate, septic shock rate, extrarenal epuration rate, cerebral vascular injury rate, Major Cardiac Adverse Events at 30-days, mortality at 30 days.
Method: This is a multicenter (5 french university centers) double blind randomized study compared to placebo. Patients are randomized the day before surgery (computer randomization) between L-bupivacaine and placebo which is infused with continuous local anesthetic infusion by multiperforated catheter at the end of cardiac surgery with sternotomy. Anesthesia protocol is pre-established (propofol and sufentanil with TCI and atracurium only at the induction), tranexamic acid (bolus of 20 mg/kg and 2mg/kg/h). Total dose of each agent is reported in the electronic case report (eCRF, cleanWeb®). Antibioprophylaxy is standardized in agreement with French guidelines in cardiac surgery. Analgesic treatment is standardized as well. During the first postoperative 48 hours: paracetamol (1g x4/day), morphine sulfate (intravenous titration and immediately after the end of titration, self pain management with morphine pump during 48 hours for all the patients included in the study. Total dose of morphine sulfate is reported in the eCRF. In addition, intravenous ketoprofen may be associated in addition if requested. Multiperforated catheter is introduced at the end of surgery above steel sternal bands. A bolus of 10 ml of L-bupivacain or placebo is infused into the catheter at the end of surgery when skin suture is done. Then, the elastomeric pump is connected to the catheter for 48 postoperative hours at 8ml/hour. Extubation is done ideally in the first 6 postoperative hours and chest kinesitherapy is performed at day 1 and 2, in postoperative period. Follow up is done during 30 days after surgery.
Statistical analysis: Rate of pneumonia is expected to be 18% in the placebo group, and 12.6% in the L-bupivacaine group. The number of patients needed (with alpha=0.05, beta= 0.80) is estimated to be 1500 patients (750 patients by group). Because 5 centers are expected to participate, 15% only of eligible patients in all these centers will be enough. Twenty four months would be necessary for the inclusion with 1 month more for the follow up. Thus, the study would last 25 months.
Ethical issue: The present study will be presented to pitie salpetriere Research Ethics Board for approval. An independent Safety Board will survey the study.
Conclusion: This study should decrease the rate of pneumonia in patients undergoing cardiac surgery with sternotomy.
- Being tested
- L bupivacaine, placebo
- Keywords
- Pneumonia, Postoperative infection, Cardiac surgery, Multiperforated catheter, Analgesia
- Medical subject headings
- Pneumonia, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L bupivacaineDevice
Also called catheter with L bupivacaine
L-bupivacain solution CHIROCAINE® 5mg/ml, flakon de 20 ml): for the intravenous bolus of 10 ml
- (CHIROCAINE®1.25mg/ml, 200 mL/unit, 400 ml in the accufusor infused at 8ml/h during 48h00: for infusion during 48h00
placeboDrug
Also called Isotonic NaCl solution
- Isotonic NaCl solution (9°/00) solution: for the intravenous bolus of 10 ml
- Isotonic NaCl solution (9°/00) solution, 400 ml in the accufusor infused at 8ml/h during 48h00: for infusion during 48h00
| Study group | Role | What they receive |
|---|---|---|
| L bupivacaine | Experimental | Drug (L bupivacaine) and device (catheter) 750 patients undergoing cardiac surgery with sternotomy are treated with L-bupivacain in the multiperforated catheter of analgesia Receives: Device: L bupivacaine |
| placebo | Placebo comparator | Isotonic Nacl 9°/00 solution 750 patients undergoing cardiac surgery with sternotomy are treated with isotonic NaCl solution (placebo) in the multiperforated catheter of analgesia Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of post-operative pneumonia in hospital
Measured: 30 days
Secondary outcomes (10)
all-cause mortality
Measured: 30 days
mechanical ventilation free days
Measured: 30 days
ICU free days
Measured: 30 days
Hospital stay
Measured: 30 days
Rate of ICU readmission
Measured: 30 days
Reintubation rate
Measured: 30 days
Septic shock rate
Measured: 30 days
Extrarenal epuration rate
Measured: 30 days
Cerebral vascular injury rate
Measured: 30 days
Major Cardiac Adverse Events
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2012 (estimated)
- Study startMar 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,502 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation, WYM France, Abbott
- Responsible party
- Sponsor
- Investigators
- Julien Amour, MD, PhD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01648777
- Sponsor's protocol ID
- 2011-3289-10
- Other IDs
- A110903-48
- Acronym
- STERNOCAT
- Status last verified
- Nov 2013
- First submitted
- 20 Jul 2012
- Last updated
- 24 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dureau P, Rombi L, Ouorou R, Hariri G, Duceau B, Amour J, Bougle A, Dechartres A. Preoperative and Intraoperative Risk Factors for Postoperative Pneumonia After Cardiac Surgery: An Ancillary Study of the STERNOCAT (Catheter Outcomes With Sternotomy Cardiac Operated) Randomized Trial and a Systematic Review With Meta-Analysis. Crit Care Med. 2026 May 1;54(5):1158-1168. doi: 10.1097/CCM.0000000000007060. Epub 2026 Feb 11.
PubMed 41670402Amour J, Cholley B, Ouattara A, Longrois D, Leprince P, Fellahi JL, Riou B, Hariri S, Latremouille C, Remy A, Provenchere S, Carillion A, Achouh P, Labrousse L, Tran Dinh A, Ait Hamou N, Charfeddine A, Lafourcade A, Hajage D, Bougle A; STERNOCAT investigators. The effect of local anesthetic continuous wound infusion for the prevention of postoperative pneumonia after on-pump cardiac surgery with sternotomy: the STERNOCAT randomized clinical trial. Intensive Care Med. 2019 Jan;45(1):33-43. doi: 10.1007/s00134-018-5497-x. Epub 2019 Jan 7.
PubMed 30617461
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cicatricial Analgesia Catheters Outcome on Bronchopulmonary Infection Number With Sternotomy Cardiac Operated
- ClinicalTrials.gov ID
- NCT01648777
- Acronym / sponsor ID
- STERNOCAT / 2011-3289-10
- Keywords
- Pneumonia, Postoperative infection, Cardiac surgery, Multiperforated catheter, Analgesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,502 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation, WYM France, Abbott
- Study start
- Mar 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 24 Jul 2012 (estimated)
- 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.
Pneumonia occurs frequently in patients undergoing cardiac surgery and allows to increase their mortality. While chest physical therapy plays a crucial role to prevent postoperative pneumoniae, painful mobilization of the sternum after sternotomy limits chest physical therapy. The continuous local anesthetic infusion by multiperforated catheter decreases sternum pain. Because of this optimal pain management, early chest physical therapy could be more efficient and could contribute to decrease the rate of pneumonia.
The aim of this study is to test if management of sternotomy pain using continuous local anesthetic infusion by multiperforated catheter may contribute to decrease the rate of perioperative pneumonia.
Detailed description
Introduction:
Pneumonia occurs in 15 to 20% of patients undergoing cardiac surgery and allows to increase their mortality. Early non-invasive ventilation (NIV) after extubation and active and passive chest physical therapies have shown to diminish risk of respiratory failure and lowered 90-day mortality. Unfortunately, pain after cardiac surgery is mainly related to the median sternotomy. The mobilization of the sternum after sternotomy induces paroxysmal and periodical pain, sorely control by opioid treatment, regulated by the chest movements of ventilation or chest mobilization such during NIV or chest physical therapy. The continuous local anesthetic infusion by multiperforated catheter has been shown to be effective for decreasing paroxysmal sternum pain, opioid analgesic medication, length of intensive care medicine (ICU) and hospital stay. Because of this better pain management, early NIV and chest physical therapy could be more efficient and could contribute to decrease the rate of pneumonia in patients undergoing cardiac surgery with sternotomy.
Hypothesis: The aim of this study is to test if management of sternotomy pain using continuous local anesthetic infusion by multiperforated catheter may contribute to decrease the rate of perioperative pneumonia.
Primary end-point: Rate of post-operative pneumonia in hospital. Secondary end-points: post operative quality of Analgesia (total morphine consumption), 30-days all-cause mortality, mechanical ventilation free days, ICU free days, hospital stay, rate of ICU readmission, reintubation rate, septic shock rate, extrarenal epuration rate, cerebral vascular injury rate, Major Cardiac Adverse Events at 30-days, mortality at 30 days.
Method: This is a multicenter (5 french university centers) double blind randomized study compared to placebo. Patients are randomized the day before surgery (computer randomization) between L-bupivacaine and placebo which is infused with continuous local anesthetic infusion by multiperforated catheter at the end of cardiac surgery with sternotomy. Anesthesia protocol is pre-established (propofol and sufentanil with TCI and atracurium only at the induction), tranexamic acid (bolus of 20 mg/kg and 2mg/kg/h). Total dose of each agent is reported in the electronic case report (eCRF, cleanWeb®). Antibioprophylaxy is standardized in agreement with French guidelines in cardiac surgery. Analgesic treatment is standardized as well. During the first postoperative 48 hours: paracetamol (1g x4/day), morphine sulfate (intravenous titration and immediately after the end of titration, self pain management with morphine pump during 48 hours for all the patients included in the study. Total dose of morphine sulfate is reported in the eCRF. In addition, intravenous ketoprofen may be associated in addition if requested. Multiperforated catheter is introduced at the end of surgery above steel sternal bands. A bolus of 10 ml of L-bupivacain or placebo is infused into the catheter at the end of surgery when skin suture is done. Then, the elastomeric pump is connected to the catheter for 48 postoperative hours at 8ml/hour. Extubation is done ideally in the first 6 postoperative hours and chest kinesitherapy is performed at day 1 and 2, in postoperative period. Follow up is done during 30 days after surgery.
Statistical analysis: Rate of pneumonia is expected to be 18% in the placebo group, and 12.6% in the L-bupivacaine group. The number of patients needed (with alpha=0.05, beta= 0.80) is estimated to be 1500 patients (750 patients by group). Because 5 centers are expected to participate, 15% only of eligible patients in all these centers will be enough. Twenty four months would be necessary for the inclusion with 1 month more for the follow up. Thus, the study would last 25 months.
Ethical issue: The present study will be presented to pitie salpetriere Research Ethics Board for approval. An independent Safety Board will survey the study.
Conclusion: This study should decrease the rate of pneumonia in patients undergoing cardiac surgery with sternotomy.
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 |
|---|---|---|
| L bupivacaine | Experimental | Device: L bupivacaineDrug (L bupivacaine) and device (catheter) 750 patients undergoing cardiac surgery with sternotomy are treated with L-bupivacain in the multiperforated catheter of analgesia |
| placebo | Placebo comparator | Drug: placeboIsotonic Nacl 9°/00 solution 750 patients undergoing cardiac surgery with sternotomy are treated with isotonic NaCl solution (placebo) in the multiperforated catheter of analgesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- all patient more than 18 years old
- planned cardiac surgery with sternotomy and bypass
- Informed consent written
Key exclusion criteria (12 listed)
- Refusal of patient to be included in the study
- Age less than 18 years old
- Pregnancy
- Emergency
- Prolonged sedation and ventilation more than 48h00 expected in teh postoperative period
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 |
|---|---|---|
| L bupivacaineAlso: catheter with L bupivacaineL-bupivacain solution CHIROCAINE® 5mg/ml, flakon de 20 ml): for the intravenous bolus of 10 ml o (CHIROCAINE®1.25mg/ml, 200 mL/unit, 400 ml in the accufusor infused at 8ml/h during 48h00: for infusion during 48h00 | Device | L bupivacaine |
| placeboAlso: Isotonic NaCl solution* Isotonic NaCl solution (9°/00) solution: for the intravenous bolus of 10 ml * Isotonic NaCl solution (9°/00) solution, 400 ml in the accufusor infused at 8ml/h during 48h00: for infusion during 48h00 | Drug | placebo |
Primary outcome
Rate of post-operative pneumonia in hospital
Time frame: 30 days
10 secondary outcomes
all-cause mortality
Time frame: 30 days
mechanical ventilation free days
Time frame: 30 days
ICU free days
Time frame: 30 days
Hospital stay
Time frame: 30 days
Rate of ICU readmission
Time frame: 30 days
Reintubation rate
Time frame: 30 days
Septic shock rate
Time frame: 30 days
Extrarenal epuration rate
Time frame: 30 days
Cerebral vascular injury rate
Time frame: 30 days
Major Cardiac Adverse Events
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2015.
- Derived from this study: PubMed 41670402Dureau P, Rombi L, Ouorou R, Hariri G, Duceau B, Amour J, Bougle A, Dechartres A. Preoperative and Intraoperative Risk Factors for Postoperative Pneumonia After Cardiac Surgery: An Ancillary Study of the STERNOCAT (Catheter Outcomes With Sternotomy Cardiac Operated) Randomized Trial and a Systematic Review With Meta-Analysis. Crit Care Med. 2026 May 1;54(5):1158-1168. doi: 10.1097/CCM.0000000000007060. Epub 2026 Feb 11.
- Derived from this study: PubMed 30617461Amour J, Cholley B, Ouattara A, Longrois D, Leprince P, Fellahi JL, Riou B, Hariri S, Latremouille C, Remy A, Provenchere S, Carillion A, Achouh P, Labrousse L, Tran Dinh A, Ait Hamou N, Charfeddine A, Lafourcade A, Hajage D, Bougle A; STERNOCAT investigators. The effect of local anesthetic continuous wound infusion for the prevention of postoperative pneumonia after on-pump cardiac surgery with sternotomy: the STERNOCAT randomized clinical trial. Intensive Care Med. 2019 Jan;45(1):33-43. doi: 10.1007/s00134-018-5497-x. Epub 2019 Jan 7.
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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.
Julien Amour, MD, PhD principal investigator
APHP
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 L bupivacaine in people with Pneumonia and Cardiac Surgery, run by Assistance Publique - Hôpitaux de Paris 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 3 inclusion and 12 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 24 Apr 2015. 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. 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 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?
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?
Rate of post-operative pneumonia in hospital (time frame: 30 days). 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 NCT01648777, which also lists 2 linked publications.
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 24 Apr 2015.