Ropivacaine Though Laterosternal Catheters After Cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2010-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ropivacaine

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Parallel study with two groups:

1. ropivacaine (2 mg.mL-1), at the rate of 4 mL.hr-1 through two subcutaneous catheters lateral to the sternum, both alimented by an elastomeric pump.
2. same protocol, with normal saline instead of ropivacaine.

normal saline

Group Type OTHER

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

Intervention Type DRUG

Parallel study with two groups:

1. ropivacaine (2 mg.mL-1), at the rate of 4 mL.hr-1 through two subcutaneous catheters lateral to the sternum, both alimented by an elastomeric pump.
2. same protocol, with normal saline instead of ropivacaine.

Interventions

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

Parallel study with two groups:

1. ropivacaine (2 mg.mL-1), at the rate of 4 mL.hr-1 through two subcutaneous catheters lateral to the sternum, both alimented by an elastomeric pump.
2. same protocol, with normal saline instead of ropivacaine.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No