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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00724685

Enrollment

Registered

2008-07-29

Start date

2008-01-31

Completion date

2011-11-30

Last updated

2013-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Analgesia

Keywords

Ropivacaine, elastomeric pump, patient controlled analgesia, morphine consumption

Brief 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.

Interventions

DRUGNaropeine (Ropivacaine)

DRUGPlacebo

saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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)

Design outcomes

Primary

Measure	Time frame
Total morphine consumption	H 48

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026