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

This study has been terminated.
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00724685
First received: July 25, 2008
Last updated: February 7, 2013
Last verified: February 2013

July 25, 2008
February 7, 2013
January 2008
November 2011   (final data collection date for primary outcome measure)
Total morphine consumption [ Time Frame: H 48 ]
Total morphine consumption at H 48
Complete list of historical versions of study NCT00724685 on ClinicalTrials.gov Archive Site
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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

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.

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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Post Operative Analgesia
  • Drug: Naropeine (Ropivacaine)
  • Drug: Placebo
    saline
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Active
    Intervention: Drug: Naropeine (Ropivacaine)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
34
November 2011
November 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • operated for latissimus dorsi and serratus micro anastomotic flaps.
  • 18 to 75 years old
  • ASA I-II
  • hospitalized in Nantes CHU Burns ICU
  • giving their written informed consent
  • with healthcare protection

Exclusion Criteria:

  • declining the study
  • with known sides effects with morphine and local anesthetics
  • with known allergy or other reaction with used drugs
  • with disease incompatible with anaesthetic procedure
  • under law protection
  • taking antiepileptic or antidepressant drugs
  • pregnant (not any gender criteria)
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00724685
BRD07/3-Y, Eudract 2007-002983-89
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Nantes University Hospital
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Not Provided
Nantes University Hospital
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP