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

Phase 4

Terminated

• Conditions: Post Operative Analgesia
• Interventions: Drug: Placebo; Drug: Naropeine (Ropivacaine)

• Registration Number: NCT00724685
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-07-28
• Study First Posted: 2008-07-29
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-07
• Last Update Posted: 2013-02-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Active	Naropeine (Ropivacaine)	-

Primary Outcome Measures

Name	Time	Method
Total morphine consumption	H 48

Trial Locations

Locations (1)

CHU; 🇫🇷 Nantes, France