Continuous Regional Anesthesia for Septic Limb Orthopedic Surgery (ACOSM)

September 17, 2013 updated by: University Hospital, Strasbourg, France

This study aims to assess the safety of using continuous regional anesthesia for post-operative analgesia during septic limb orthopedic surgery.

The study hypothesis is that continuous regional anesthesia would not induce septic complication in the operated limb and could improve post-operative recovery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

260

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Alsace
      • Illkirch, Alsace, France, 67400
        • CCOM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Osteo arthritis or cellulitis requiring surgical intervention
  • anatomical possibility of regional anesthesia
  • age >18 ans
  • written informed consent

Exclusion Criteria:

  • loco-regional anesthesia impossibility (puncture zone infection, local anesthesics allergie, amiodarone or mexilétine treatment, neurologic deficit for exemple)
  • patient under tutelle or curatelle
  • pregnant or beast feeding woman

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Continuous regional anesthesia
Drug: Systemic analgesia + Continuous regional anesthesia
Systemic analgesia + Continuous regional anesthesia, peri neural for the 2 to 4 first days post-operative
ACTIVE_COMPARATOR: Systemic analgesia
Drug: Systemic analgesia
Systemic analgesia as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Septic complication in the operated limb
Time Frame: 28 days
Septic complication in the operated limb Pain score Nausea and vomiting
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (ANTICIPATED)

November 1, 2015

Study Completion (ANTICIPATED)

November 1, 2015

Study Registration Dates

First Submitted

September 17, 2013

First Submitted That Met QC Criteria

September 17, 2013

First Posted (ESTIMATE)

September 20, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

September 20, 2013

Last Update Submitted That Met QC Criteria

September 17, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5492

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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