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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-11-30

Brief Summary

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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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Detailed Description

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Conditions

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Post Operative Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

saline

Active

Group Type EXPERIMENTAL

Naropeine (Ropivacaine)

Intervention Type DRUG

Interventions

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Naropeine (Ropivacaine)

Intervention Type DRUG

Placebo

saline

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No