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NCT01947660 Clinical Trial

Continuous Regional Anesthesia for Septic Limb Orthopedic Surgery

Cellulitis Clinical Trial

— ACOSM  

Official title:
Continuous Regional Anesthesia for Septic Limb Orthopedic Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01947660
Other study ID # 5492
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 17, 2013
Last updated September 17, 2013
Start date October 2013
Est. completion date November 2015

Study information
Verified date September 2013
Source University Hospital, Strasbourg, France
Contact Pierre DIEMUNSCH, PU PH
Phone 03 88 12 70 76
Email pierre.diemunsch@chru-strasbourg.fr
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 260
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Systemic analgesia + Continuous regional anesthesia
Systemic analgesia + Continuous regional anesthesia, peri neural for the 2 to 4 first days post-operative
• Systemic analgesia
Systemic analgesia as usual

Locations
Country Name City State
France CCOM Illkirch Alsace

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Septic complication in the operated limb Septic complication in the operated limb Pain score Nausea and vomiting 28 days No
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