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Continuous Regional Anesthesia for Septic Limb Orthopedic Surgery (ACOSM)

Primary Purpose

Osteo Arthritis, Cellulitis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Systemic analgesia + Continuous regional anesthesia
Systemic analgesia
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CCOM

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Continuous regional anesthesia

Systemic analgesia

Arm Description

Outcomes

Primary Outcome Measures

Septic complication in the operated limb
Septic complication in the operated limb Pain score Nausea and vomiting

Secondary Outcome Measures

Full Information

First Posted
September 17, 2013
Last Updated
September 17, 2013
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT01947660
Brief Title
Continuous Regional Anesthesia for Septic Limb Orthopedic Surgery
Acronym
ACOSM
Official Title
Continuous Regional Anesthesia for Septic Limb Orthopedic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
November 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis, Cellulitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Continuous regional anesthesia
Arm Type
Experimental
Arm Title
Systemic analgesia
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Systemic analgesia + Continuous regional anesthesia
Intervention Description
Systemic analgesia + Continuous regional anesthesia, peri neural for the 2 to 4 first days post-operative
Intervention Type
Drug
Intervention Name(s)
Systemic analgesia
Intervention Description
Systemic analgesia as usual
Primary Outcome Measure Information:
Title
Septic complication in the operated limb
Description
Septic complication in the operated limb Pain score Nausea and vomiting
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre DIEMUNSCH, PU PH
Phone
03 88 12 70 76
Email
pierre.diemunsch@chru-strasbourg.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Eric NOLL, PH
Phone
03 88 55 23 37
Email
eric.noll@chru-strasbourg.fr
Facility Information:
Facility Name
CCOM
City
Illkirch
State/Province
Alsace
ZIP/Postal Code
67400
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric NOLL, PH
Phone
03 88 55 23 37
First Name & Middle Initial & Last Name & Degree
KEMPF, PU PH
First Name & Middle Initial & Last Name & Degree
NOLL, PH
First Name & Middle Initial & Last Name & Degree
GAUDIAS, PH
First Name & Middle Initial & Last Name & Degree
JENNY, PH
First Name & Middle Initial & Last Name & Degree
CLAVERT, PU PH
First Name & Middle Initial & Last Name & Degree
LAALOU, PH
First Name & Middle Initial & Last Name & Degree
BOERI, PH

12. IPD Sharing Statement

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Continuous Regional Anesthesia for Septic Limb Orthopedic Surgery

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