Ropivacaine Though Laterosternal Catheters After Cardiac Surgery

Phase 4

Completed

• Conditions: Cardiac Surgery
• Interventions: Drug: Ropivacaine (in one arm); catheterization (in both).

• Registration Number: NCT01196767
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-26
• Study First Submitted QC: 2010-09-07
• Study First Posted: 2010-09-08
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-02
• Last Update Posted: 2013-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ropivacaine	Ropivacaine (in one arm); catheterization (in both).	-
normal saline	Ropivacaine (in one arm); catheterization (in both).	-

Primary Outcome Measures

Name	Time	Method
Pain score at mobilization (lying position for measurement of central venous pressure), expressed on a visual analogue scale.	every 4 hours during 48 hours

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events	daily during 48 hours	nausea and vomiting, pruritus
Postoperative blood level of ropivacaine at day + 1 and day + 2	daily during 48 hours
Pain score at rest, expressed on a visual analogue scale.	every 4 hours during 48 hours
Arterial blood gases	every 4 hours during 48 hours
Postoperative blood level of troponin	every 8 hours during 48 hours
Time to first flatus	daily during 48 hours
Morphine consumption on PCA device	every 4 hours during 48 hours
Vital capacity and inspiratory reserve volume, related to the preoperative values	daily during 48 hours
Signs of intoxication to ropivacaine	eventual reports

Trial Locations

Locations (1)

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