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

Nantes University Hospital (NUH)

Status and phase: Terminated; Phase 4

Conditions: Post Operative Analgesia

Treatments: Drug: Naropeine (Ropivacaine); Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00724685

BRD07/3-Y

Eudract 2007-002983-89

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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34 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Active

Experimental group

Treatment:

Drug: Naropeine (Ropivacaine)