Continuous Regional Anesthesia for Septic Limb Orthopedic Surgery (ACOSM)

University Hospital, Strasbourg, France

Status: Unknown

Conditions: Cellulitis; Osteo Arthritis

Treatments: Drug: Systemic analgesia; Drug: Systemic analgesia + Continuous regional anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT01947660

5492

Details and patient eligibility

About

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.

Enrollment: 260 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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260 participants in 2 patient groups

Continuous regional anesthesia

Experimental group

Treatment:

Drug: Systemic analgesia + Continuous regional anesthesia

Systemic analgesia

Active Comparator group

Treatment:

Drug: Systemic analgesia