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Continuous Regional Anesthesia for Septic Limb Orthopedic Surgery (ACOSM)

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ClinicalTrials.gov Identifier: NCT01947660
Recruitment Status : Unknown
Verified September 2013 by University Hospital, Strasbourg, France.
Recruitment status was:  Not yet recruiting
First Posted : September 20, 2013
Last Update Posted : September 20, 2013
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

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.


Condition or disease Intervention/treatment Phase
Osteo Arthritis Cellulitis Drug: Systemic analgesia + Continuous regional anesthesia Drug: Systemic analgesia Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Continuous Regional Anesthesia for Septic Limb Orthopedic Surgery
Study Start Date : October 2013
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Septic complication in the operated limb [ Time Frame: 28 days ]
    Septic complication in the operated limb Pain score Nausea and vomiting



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01947660


Contacts
Contact: Pierre DIEMUNSCH, PU PH 03 88 12 70 76 pierre.diemunsch@chru-strasbourg.fr
Contact: Eric NOLL, PH 03 88 55 23 37 eric.noll@chru-strasbourg.fr

Locations
France
CCOM Not yet recruiting
Illkirch, Alsace, France, 67400
Contact: Eric NOLL, PH    03 88 55 23 37      
Sub-Investigator: KEMPF, PU PH         
Sub-Investigator: NOLL, PH         
Sub-Investigator: GAUDIAS, PH         
Sub-Investigator: JENNY, PH         
Sub-Investigator: CLAVERT, PU PH         
Sub-Investigator: LAALOU, PH         
Sub-Investigator: BOERI, PH         
Sponsors and Collaborators
University Hospital, Strasbourg, France

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01947660     History of Changes
Other Study ID Numbers: 5492
First Posted: September 20, 2013    Key Record Dates
Last Update Posted: September 20, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Cellulitis
Osteoarthritis
Skin Diseases, Infectious
Infection
Suppuration
Connective Tissue Diseases
Inflammation
Pathologic Processes
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs