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.

Study Overview

• Status: Terminated
• Conditions: Post Operative Analgesia
• Intervention / Treatment: Drug: Placebo; Drug: Naropeine (Ropivacaine)

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44093
    • CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; saline
Experimental: Active	Drug: Naropeine (Ropivacaine)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total morphine consumption	H 48

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: July 25, 2008
• First Submitted That Met QC Criteria: July 28, 2008
• First Posted (Estimate): July 29, 2008

Study Record Updates

• Last Update Posted (Estimate): February 8, 2013
• Last Update Submitted That Met QC Criteria: February 7, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Ropivacaine; patient controlled analgesia; morphine consumption; elastomeric pump
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: BRD07/3-Y; Eudract 2007-002983-89