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

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ClinicalTrials.gov Identifier: NCT01828788
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : July 4, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief 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.

Condition or disease Intervention/treatment Phase
Scheduled Cardiac Surgery Sternotomy Elderly Patients Obesity Chronic Bronchitis Drug: Ropivacaine Drug: placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Postoperative Rehabilitation After Cardiac Surgery in Patients at Risk of Respiratory Complications. Effects of a Continuous Bi-laterosternal Infusion of Ropivacaine Through Multihole Catheters.
Actual Study Start Date : April 27, 2013
Actual Primary Completion Date : January 19, 2015
Actual Study Completion Date : January 19, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. The deadline for obtaining all criteria consistent with an output of postoperative intensive care [ Time Frame: 72 hours ]
    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].


Secondary Outcome Measures :
  1. Surgery time [ Time Frame: 24 hours ]
  2. Quantity of sufentanil administered [ Time Frame: 72 hours ]
  3. Total morphine consumption [ Time Frame: 72 hours ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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, BMI over 30, pulmonary disease, or active smoking habit

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828788


Locations
France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Vedat Eljezi University Hospital, Clermont-Ferrand

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01828788     History of Changes
Other Study ID Numbers: CHU-0151
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: July 2018

Keywords provided by University Hospital, Clermont-Ferrand:
Sternotomy
Anesthesia
Post-operative pain

Additional relevant MeSH terms:
Bronchitis
Bronchitis, Chronic
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Pulmonary Disease, Chronic Obstructive
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents