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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

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

Condition Intervention Phase
Post Operative Analgesia
Drug: Naropeine (Ropivacaine)
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Interest of Continuous Ropivacaine Administration Through an Elastomeric Pump (Pain Buster ) for the Surgery of Latissimus Dorsi and Serratus Micro Anastomotic Flaps

Resource links provided by NLM:

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Total morphine consumption [ Time Frame: H 48 ]

Enrollment: 34
Study Start Date: January 2008
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Experimental: Active Drug: Naropeine (Ropivacaine)


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
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Please refer to this study by its identifier: NCT00724685

Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
  More Information Identifier: NCT00724685     History of Changes
Other Study ID Numbers: BRD07/3-Y
Eudract 2007-002983-89
Study First Received: July 25, 2008
Last Updated: February 7, 2013

Keywords provided by Nantes University Hospital:
elastomeric pump
patient controlled analgesia
morphine consumption

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on May 25, 2017