Continuous Regional Anesthesia for Septic Limb Orthopedic Surgery

NCT ID: NCT01947660

Last Updated: 2013-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-11-30

Brief Summary

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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

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Conditions

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Osteo Arthritis Cellulitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Continuous regional anesthesia

Group Type EXPERIMENTAL

Systemic analgesia + Continuous regional anesthesia

Intervention Type DRUG

Systemic analgesia + Continuous regional anesthesia, peri neural for the 2 to 4 first days post-operative

Systemic analgesia

Group Type ACTIVE_COMPARATOR

Systemic analgesia

Intervention Type DRUG

Systemic analgesia as usual

Interventions

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Systemic analgesia + Continuous regional anesthesia

Systemic analgesia + Continuous regional anesthesia, peri neural for the 2 to 4 first days post-operative

Intervention Type DRUG

Systemic analgesia

Systemic analgesia as usual

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CCOM

Illkirch-Graffenstaden, Alsace, France

Site Status

Countries

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France

Central Contacts

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Pierre DIEMUNSCH, PU PH

Role: CONTACT

Phone: 03 88 12 70 76

Email: [email protected]

Eric NOLL, PH

Role: CONTACT

Phone: 03 88 55 23 37

Email: [email protected]

Facility Contacts

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Eric NOLL, PH

Role: primary

Other Identifiers

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5492

Identifier Type: -

Identifier Source: org_study_id