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CompletedNCT01828788BLS-SternoUpdated Aug 6, 2026

Postoperative Rehabilitation After Cardiac Surgery in Patients at Risk of Respiratory Complications. Effects of a Continuous Bi-laterosternal Infusion of Ropivacaine Through Multihole Catheters

A Phase 2 interventional study of Ropivacaine and placebo in Scheduled Cardiac Surgery, Sternotomy and Elderly Patients, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-06.

Sponsored by University Hospital, Clermont-Ferrand · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

Postoperative pain after cardiac surgery is a risk factor for postoperative complications. In cardiac surgery, pain is more intense during the first 48 hours and disturbs the patient's capacity of coughing, deep breathing, and early mobilisation. It may be responsible for respiratory complications such as bronchial or pulmonary infection, and may also delay the patient's rehabilitation and therefore prolong the duration of in-hospital stay. A previous pilot study performed in our department showed a sensible improvement of analgesia at movement and of rehabilitation with a continuous bilaterosternal infusion of local anaesthesia [Eljezi et al.. Reg Anesth Pain Med 2012; 37:166]. Such strategy shall be tested in a subpopulation of patients at risk for respiratory complication.

Read the detailed description

Prospective, controlled, randomised, parallel, single-centre, single-blinded trial, comparing to a control (conventional care with no locoregional anaesthesia) an infusion of ropivacaine through two multihole catheters placed lateral to the sternum. In both groups, postoperative analgesia will be achieved by paracetamol plus titrated then self-administered intravenous morphine.

02

Conditions studied

  • Scheduled Cardiac Surgery
  • Sternotomy
  • Elderly Patients
  • Obesity
  • Chronic Bronchitis

Keywords

  • Sternotomy
  • Anesthesia
  • Post-operative pain
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's enrollment of 120 is above the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 859 studies on the registry; 179 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Scheduled cardiac surgery (aortic or mitral valve replacement, or coronary bypass surgery) with sternotomy.
  • Patients will be at risk of noncardiac postoperative complications, i.e. age over 75, over 30, pulmonary disease, or active smoking habit

Exclusion criteria

Exclusion Criteria:

  • surgery in emergency
  • thoracotomy
  • cardiac graft
  • redo
  • aortic dissection
  • age over 85
  • pregnancy
  • patient's refusal
  • minor or adult under legal protection
  • psychiatric ongoing disease
  • addiction to opiates
  • ongoing opiate treatment
  • inability to use a PCA device
  • respiratory insufficiency (Vital capacity or maximal expired volume per sec. \< 50% of the expected value, or mean PAP > 50 mmHg)
  • cardiac failure or EF \< 40% or intra-aortic balloon use
  • pulmonary hypertension over 50 mmHg
  • severe renal insufficiency
  • history of allergy or intolerance to: morphine, acetaminophen, ropivacaine.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    Ropivacaïne

    Prospective, controlled, randomised, parallel, single-centre, single-blinded trial, comparing to a control (conventional care with no locoregional anaesthesia) an infusion of ropivacaine through two multihole catheters placed lateral to the sternum. In both groups, postoperative analgesia will be achieved by paracetamol plus titrated then self-administered intravenous morphine.

    Drug: Ropivacaine

  • Placebo comparator
    Placebo

    Prospective, controlled, randomised, parallel, single-centre, single-blinded trial, comparing to a control (conventional care with no locoregional anaesthesia) an infusion of ropivacaine through two multihole catheters placed lateral to the sternum. In both groups, postoperative analgesia will be achieved by paracetamol plus titrated then self-administered intravenous morphine.

    Drug: placebo

Interventions

06

What researchers measure

Primary outcomes

  1. The deadline for obtaining all criteria consistent with an output of postoperative intensive care

    The criteria will be considered by an independent adjudication committee unaware of the treatment given, according to a predefined checklist, whatever the actual delay for discharge. The checklist was built with the help of published recommendations \[Camp et al. J Card Surg 2009; 24:414\].

    Time frame: 72 hours

Secondary outcomes

  1. Surgery time

    Time frame: 24 hours

  2. Quantity of sufentanil administered

    Time frame: 72 hours

  3. Total morphine consumption

    Time frame: 72 hours

07

Study locations

1 site
  • CHU Clermont-Ferrand
    Clermont-Ferrand, 63003, France
08

References and documents

Publications

  • Eljezi V, Imhoff E, Bourdeaux D, Pereira B, Farhat M, Schoeffler P, Azarnoush K, Duale C. Bilateral sternal infusion of ropivacaine and length of stay in ICU after cardiac surgery with increased respiratory risk: A randomised controlled trial. Eur J Anaesthesiol. 2017 Feb;34(2):56-65. doi: 10.1097/EJA.0000000000000564. PubMed 27977439 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2013 to primary completion in Jan 2015, 20 months.

Of 132 non-industry phase 2 interventional studies under Obesity, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 57. This study's 20 months is below that.

Counting every sponsor, half of 308 studies reached it within 16 months; a quarter within 10 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 2, 2013
First posted
Apr 11, 2013
StartActual
Apr 27, 2013
Primary completionActual
Jan 19, 2015
CompletionActual
Jan 19, 2015
Last update
Aug 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01828788
Responsible party
Sponsor
First posted
Apr 11, 2013
Start date
Apr 27, 2013
Primary completion
Jan 19, 2015
Completion
Jan 19, 2015
Last update
Aug 6, 2026

Study contacts

Vedat Eljezi
principal investigator · University Hospital, Clermont-Ferrand
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Ropivacaine

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