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

Phase 2

Completed

• Conditions: Obesity; Scheduled Cardiac Surgery; Sternotomy; Elderly Patients; Chronic Bronchitis
• Interventions: Drug: placebo; Drug: Ropivacaine

• Registration Number: NCT01828788
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2013-04-02
• Study First Submitted QC: 2013-04-10
• Study First Posted: 2013-04-11
• Study Start: 2013-04-27
• Primary Completion: 2015-01-19
• Study Completion: 2015-01-19
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-03
• Last Update Posted: 2018-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Ropivacaïne	Ropivacaine	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.

Primary Outcome Measures

Name	Time	Method
The deadline for obtaining all criteria consistent with an output of postoperative intensive care	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

Name	Time	Method
Quantity of sufentanil administered	72 hours
Surgery time	24 hours
Total morphine consumption	72 hours

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France