Continuous Regional Anesthesia for Septic Limb Orthopedic... | NCT01947660

Studies
Continuous Regional Anesthesia for Septic Limb Orthopedic Surgery

NCT01947660

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Sep 20, 2013Estimated

Enrollment

260Estimated

Phase

Not Applicable

Conditions

Osteo Arthritis
Cellulitis

Interventions

Systemic analgesia + Continuous regional anesthesia
Systemic analgesia

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Nov 2015Estimated

Completion Date

Nov 2015Estimated

First Submitted Date

Sep 17, 2013

First Submission Date that Met QC Criteria

Sep 17, 2013

First Posted Date

Sep 20, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2013

Last Update Posted Date

Sep 20, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

260Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Continuous regional anesthesia	Experimental		Drug: Systemic analgesia + Continuous regional anesthesia
Systemic analgesia	Active Comparator		Drug: Systemic analgesia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Systemic analgesia + Continuous regional anesthesia	Drug	Systemic analgesia + Continuous regional anesthesia, peri neural for the 2 to 4 first days post-operative	Continuous regional anesthesia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Septic complication in the operated limb	Septic complication in the operated limb Pain score Nausea and vomiting	28 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Pierre DIEMUNSCH, PU PH	Contact	03 88 12 70 76		pierre.diemunsch@chru-strasbourg.fr
Eric NOLL, PH	Contact	03 88 55 23 37		eric.noll@chru-strasbourg.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CCOM		Illkirch-Graffenstaden	Alsace	67400	France

Condition Browse Module

MeSH Terms

ID	Term
D002481	Cellulitis

Ancestor Terms

ID	Term
D012874	Skin Diseases, Infectious
D007239	Infections
D013492	Suppuration
D003240	Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided