Ropivacaine Though Laterosternal Catheters After Cardiac Surgery

Phase 4CompletedNCT01196767

University Hospital, Clermont-Ferrand40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Cardiac Surgery

Interventions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Outcomes

Primary Outcomes

Pain score at mobilization (lying position for measurement of central venous pressure), expressed on a visual analogue scale.

Time frame: every 4 hours during 48 hours

Secondary Outcomes

Morphine consumption on PCA device

Time frame: every 4 hours during 48 hours

Pain score at rest, expressed on a visual analogue scale.

Time frame: every 4 hours during 48 hours

Vital capacity and inspiratory reserve volume, related to the preoperative values

Time frame: daily during 48 hours

Postoperative blood level of troponin

Time frame: every 8 hours during 48 hours

Arterial blood gases

Time frame: every 4 hours during 48 hours

Time to first flatus

Time frame: daily during 48 hours

Number of participants with adverse events

nausea and vomiting, pruritus

Time frame: daily during 48 hours

Postoperative blood level of ropivacaine at day + 1 and day + 2

Time frame: daily during 48 hours

Signs of intoxication to ropivacaine

Time frame: eventual reports

Data from ClinicalTrials.gov

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