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

Post Operative Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00724685
• Other study ID #: BRD07/3-Y
• Secondary ID: Eudract 2007-002
• Status: Terminated
• Phase: Phase 4
• First received: July 25, 2008
• Last updated: February 7, 2013
• Start date: January 2008
• Est. completion date: November 2011

Study information

• Verified date: February 2013
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post Operative Analgesia

Intervention

Drug:
• Naropeine (Ropivacaine)

• Placebo
saline

Locations

Country	Name	City	State
France	CHU	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total morphine consumption		H 48