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Local Anesthetic Infusion and Sternotomy

NCT00802048 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2011-12-13

No results posted yet for this study

Summary

Cardiac surgery often induces acute postoperative pain and moreover chronic dysesthesia frequently occur long-term after sternotomy. The high doses of intraoperative opioïds are well known to enhance postoperative hyperalgesia (HA) and a perioperative local anesthetic agent infusion is one of the therapeutic strategies used to limit this phenomena. The aim of this study was to evaluate the effectiveness of a continuous Ropivacaïne sternal infusion compared with a saline serum infusion to limit postoperative HA, pain and morphine consumption (M) after sternotomy in cardiac surgery.

This strategy could lead to lower postoperative morphine consumption and opioïd induced hyperalgesia.

Conditions

Interventions

DRUG

Local anesthetic (Ropivacaine)

Local anesthetic infusion

DRUG

Saline

Saline serum infusion

Sponsors & Collaborators

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Olivier POUQUET, Dr · University Hospital, Bordeaux

  • Antoine BENARD, Dr · University Hospital, Bordeaux

  • Mathieu LAFARGUE, MD · University Hospital, Bordeaux

  • Alexandre OUATTARA, MD · University Hospital, Bordeaux

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2010-01-31
Completion
2010-08-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00802048 on ClinicalTrials.gov