Complications and Adverse Effects in Continuous Periphera... | NCT00251654

Studies
Complications and Adverse Effects in Continuous Peripheral Regional Anesthesia

NCT00251654

Sponsor

Rechbergklinik Bretten

Status

Completed

Last Update Posted

Oct 1, 2009Estimated

Enrollment

9,000Actual

Phase

Not provided

Conditions

Infection
Inflammation
Adverse Effects

Interventions

perineural block (anesthesia)

Countries

Germany

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 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2002

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Nov 9, 2005

First Submission Date that Met QC Criteria

Nov 9, 2005

First Posted Date

Nov 10, 2005Estimated

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 30, 2009

Last Update Posted Date

Oct 1, 2009Estimated

Name	Class
BG Unfallklinik Murnau	OTHER

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

The investigators prospectively document infectious, neurological, and other complications or adverse events occurring during peripheral regional anesthesia via a catheter using computer-based data recording.

Detailed Description

Perineural blocks with catheter placement are more and more frequently used. Few data dealing with infectious complications of perineural catheters exist. We assess incidence and localization of infectious complications of perineural catheters by means of computerized data acquisition. We prospectively evaluate perineural catheters placed at different sites for regional anesthesia and postoperative analgesia. The catheters were placed under standardized sterile conditions by using the nerve stimulator technique. Local inflammation is defined as the presence of at least two of the three signs: redness, pain on pressure or swelling. Infection is defined as the presence of at least two of the following criteria: pus at the catheter insertion site, fever, increased CRP and/or leukocytes requiring antibiotic therapy.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

9,000Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
perineural block (anesthesia)	Procedure	continuous peripheral regional anesthesia ropivacaine 0.33% for 3 to 5 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients receiving perineural blocks via catheter

Exclusion criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients receiving perineural blocks via catheter ASA 1 to 4

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Johannes Büttner, MD	BG Unfallklinik Murnau	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
BG Unfallklinik		Murnau am Staffelsee	Bavaria	82418	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16193317	Result	Neuburger M, Breitbarth J, Reisig F, Lang D, Buttner J. [Complications and adverse events in continuous peripheral regional anesthesia Results of investigations on 3,491 catheters]. Anaesthesist. 2006 Jan;55(1):33-40. doi: 10.1007/s00101-005-0920-4. German.
17073856	Result	Neuburger M, Buttner J, Blumenthal S, Breitbarth J, Borgeat A. Inflammation and infection complications of 2285 perineural catheters: a prospective study. Acta Anaesthesiol Scand. 2007 Jan;51(1):108-14. doi: 10.1111/j.1399-6576.2006.01173.x. Epub 2006 Nov 1.

ID	Term
D007239	Infections
D007249	Inflammation

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms