NCT01947660UnknownNot Applicable
Continuous Regional Anesthesia for Septic Limb Orthopedic Surgery
University Hospital, Strasbourg, France1 site in 1 country260 target enrollmentStarted: October 2013Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 260
- Locations
- 1
- Primary Endpoint
- Septic complication in the operated limb
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Continuous regional anesthesia
Experimental
Intervention: Systemic analgesia + Continuous regional anesthesia (Drug)
Systemic analgesia
Active Comparator
Intervention: Systemic analgesia (Drug)
Outcomes
Primary Outcomes
Septic complication in the operated limb
Time Frame: 28 days
Septic complication in the operated limb Pain score Nausea and vomiting
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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