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
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
saline
Experimental: Active Drug: Naropeine (Ropivacaine)

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00724685

Locations
France
CHU
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
  More Information

No publications provided

ClinicalTrials.gov 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
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014