NCT00724685

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 29, 2008

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

February 8, 2013

Status Verified

February 1, 2013

Enrollment Period

3.8 years

First QC Date

July 25, 2008

Last Update Submit

February 7, 2013

Conditions

Post Operative Analgesia

Keywords

Ropivacaineelastomeric pumppatient controlled analgesiamorphine consumption

Outcome Measures

Primary Outcomes (1)

  • Total morphine consumption

    H 48

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Active

EXPERIMENTAL
Drug: Naropeine (Ropivacaine)

Interventions

Naropeine (Ropivacaine)DRUG
Active
PlaceboDRUG

saline

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • operated for latissimus dorsi and serratus micro anastomotic flaps.
  • to 75 years old
  • ASA I-II
  • hospitalized in Nantes CHU Burns ICU
  • giving their written informed consent
  • with healthcare protection

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU

Nantes, 44093, France

Location

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 25, 2008

First Posted

July 29, 2008

Study Start

January 1, 2008

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

February 8, 2013

Record last verified: 2013-02

Locations

FR(1)