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

• Sponsor: Nantes University Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00724685
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Arms: 2
• Duration (Months): 46
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post Operative Analgesia	Drug: Naropeine (Ropivacaine); Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Interest of Continuous Ropivacaine Administration Through an Elastomeric Pump (Pain Buster ) for the Surgery of Latissimus Dorsi and Serratus Micro Anastomotic Flaps
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Total morphine consumption [H 48]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU	Nantes		France	44093

Sponsors and Collaborators

• Nantes University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00724685
• Other Study ID Numbers: BRD07/3-Y; Eudract 2007-002983-89
• First Posted: Jul 29, 2008
• Last Update Posted: Feb 8, 2013
• Last Verified: Feb 1, 2013

• Keywords provided by , ,: Ropivacaine; elastomeric pump; patient controlled analgesia; morphine consumption
• Additional relevant MeSH terms: Ropivacaine

Study Results

No Results Posted as of Feb 8, 2013