Ropivacaine Though Laterosternal Catheters After Cardiac Surgery

University Hospital, Clermont-Ferrand

Status and phase

Completed

Phase 4

Conditions

Cardiac Surgery

Treatments

Drug: Ropivacaine (in one arm); catheterization (in both).

Study type

Interventional

Funder types

Other

Identifiers

NCT01196767

CHU-0080

Details and patient eligibility

About

This is a prospective double-blinded and randomised study involving patients undergoing cardiac surgery with median sternotomy, the effects on postoperative analgesia of a 48-hr continuous infusion of ropivacaine 2 mg.mL-1, at the rate of 4 mL.hr-1 through two catheters inserted at the lateral edges of the sternum will be studied, versus a control group in which normal saline will be infused in the same conditions.

Full description

Diverse methods for infusion of local anaesthetics after cardiac surgery have been proposed, but none of them provided high-level evidence of efficacy. The catheters studied here are designed for a surgical insertion before closure of the sternotomy, with the aim of infusing the drug the closest possible of the terminations of intercostal nerves.

Enrollment

40 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Scheduled cardiac surgery.

Exclusion criteria

- surgery in emergency
thoracotomy
cardiac graft
redo
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 insuffiency (Vital capacity or maximal expired volume per sec. < 50% of the expected value, or mean PAP > 50 mmHg)
intra-aortic balloon
severe renal insuffiency
history of allergy or intolerance to: morphine, acetaminophen, bupivacaine.