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)

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Chronic Bronchitis; Elderly Patients; Sternotomy; Scheduled Cardiac Surgery
• Intervention / Treatment: Drug: placebo; Drug: Ropivacaine

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
• Enrollment (Actual): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Chu Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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].	72 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Surgery time	24 hours
Quantity of sufentanil administered	72 hours
Total morphine consumption	72 hours

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2013
• Primary Completion (Actual): January 19, 2015
• Study Completion (Actual): January 19, 2015

Study Registration Dates

• First Submitted: April 2, 2013
• First Submitted That Met QC Criteria: April 10, 2013
• First Posted (Estimate): April 11, 2013

Study Record Updates

• Last Update Posted (Actual): July 5, 2018
• Last Update Submitted That Met QC Criteria: July 3, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Anesthesia; Post-operative pain; Sternotomy
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Bronchitis; Bronchitis, Chronic; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: CHU-0151