Continuous Regional Anesthesia for Septic Limb Orthopedic Surgery (ACOSM)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by University Hospital, Strasbourg, France
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT01947660
First received: September 17, 2013
Last updated: NA
Last verified: September 2013
History: No changes posted
  Purpose

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 Intervention
Osteo Arthritis
Cellulitis
Drug: Systemic analgesia + Continuous regional anesthesia
Drug: Systemic analgesia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Continuous Regional Anesthesia for Septic Limb Orthopedic Surgery

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • Septic complication in the operated limb [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Septic complication in the operated limb Pain score Nausea and vomiting


Estimated Enrollment: 260
Study Start Date: October 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01947660     History of Changes
Other Study ID Numbers: 5492
Study First Received: September 17, 2013
Last Updated: September 17, 2013
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on September 11, 2014