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)

• ClinicalTrials.gov Identifier: NCT01828788
• Recruitment Status: Completed
• First Posted: April 11, 2013
• Last Update Posted: July 5, 2018
• Sponsor: University Hospital, Clermont-Ferrand
• Information provided by (Responsible Party): University Hospital, Clermont-Ferrand

Study Description

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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.

Contacts and Locations

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Eljezi V, Imhoff E, Bourdeaux D, Pereira B, Farhat M, Schoeffler P, Azarnoush K, Dualé 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.

• Responsible Party: University Hospital, Clermont-Ferrand
• ClinicalTrials.gov Identifier: NCT01828788
• Other Study ID Numbers: CHU-0151
• First Posted: April 11, 2013
• Last Update Posted: July 5, 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