Clinical Trials Directory

Trials / Terminated

TerminatedNCT00724685

Interest of Continuous Ropivacaine Administration Through an Elastomeric Pump (Pain Buster) for the Surgery of Latissimus Dorsi and Serratus Micro Anastomotic Flaps

Interest of Continuous Ropivacaine Administration Through an Elastomeric Pump (Pain Buster ) for the Surgery of Latissimus Dorsi and Serratus Micro Anastomotic Flaps

Status
Terminated
Phase
Phase 4
Study type
Interventional
Enrollment
34 (actual)
Sponsor
Nantes University Hospital · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

Continuous bupivacaine administration through an elastomeric pump (Pain Buster) has been found effective for post operative analgesia in a large range of surgery. Ropivacaine is a less toxic drug, never tested in the surgery of latissimus dorsi and serratus micro anastomotic flaps (from the investigators knowledge). The aim of the study is to evaluate the usefulness of this drug and device for post operative analgesia, associated with patient controlled analgesia with morphine. For this purpose a controlled randomized double blind trial against placebo (saline) is performed, enrolling 40 (20x2) patients during 3 years, in order to measure total morphine consumption during the first 48 post operative hours and to evaluate analgesia and sides effects of morphine in each group.

Conditions

Interventions

TypeNameDescription
DRUGNaropeine (Ropivacaine)
DRUGPlacebosaline

Timeline

Start date
2008-01-01
Primary completion
2011-11-01
Completion
2011-11-01
First posted
2008-07-29
Last updated
2013-02-08

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT00724685. Inclusion in this directory is not an endorsement.