Continuous Regional Anesthesia for Septic Limb Orthopedic Surgery

Not Applicable

• Conditions: Osteo Arthritis; Cellulitis
• Interventions: Drug: Systemic analgesia; Drug: Systemic analgesia + Continuous regional anesthesia

• Registration Number: NCT01947660
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-09
• Study First Submitted: 2013-09-17
• Study First Submitted QC: 2013-09-17
• Last Update Submitted: 2013-09-17
• Study First Posted: 2013-09-20
• Last Update Posted: 2013-09-20
• Study Start: 2013-10
• Primary Completion: 2015-11
• Study Completion: 2015-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 260

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Systemic analgesia	Systemic analgesia	-
Continuous regional anesthesia	Systemic analgesia + Continuous regional anesthesia	-

Primary Outcome Measures

Name	Time	Method
Septic complication in the operated limb	28 days	Septic complication in the operated limb Pain score Nausea and vomiting

Trial Locations

Locations (1)

CCOM; 🇫🇷 Illkirch, Alsace, France

CCOM

🇫🇷Illkirch, Alsace, France

Eric NOLL, PH

Contact

03 88 55 23 37

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

Sub Investigator