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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)

Primary Purpose

Scheduled Cardiac Surgery, Sternotomy, Elderly Patients

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Ropivacaine
placebo
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scheduled Cardiac Surgery focused on measuring Sternotomy, Anesthesia, Post-operative pain

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU Clermont-Ferrand

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ropivacaïne

Placebo

Arm 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.

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.

Outcomes

Primary Outcome Measures

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].

Secondary Outcome Measures

Surgery time
Quantity of sufentanil administered
Total morphine consumption

Full Information

First Posted
April 2, 2013
Last Updated
July 3, 2018
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT01828788
Brief 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
Acronym
BLS-Sterno
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
April 27, 2013 (Actual)
Primary Completion Date
January 19, 2015 (Actual)
Study Completion Date
January 19, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scheduled Cardiac Surgery, Sternotomy, Elderly Patients, Obesity, Chronic Bronchitis
Keywords
Sternotomy, Anesthesia, Post-operative pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ropivacaïne
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
The deadline for obtaining all criteria consistent with an output of postoperative intensive care
Description
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 Outcome Measure Information:
Title
Surgery time
Time Frame
24 hours
Title
Quantity of sufentanil administered
Time Frame
72 hours
Title
Total morphine consumption
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vedat Eljezi
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
27977439
Citation
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.
Results Reference
derived

Learn more about this trial

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

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