NCT00251654

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 10, 2005

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

October 1, 2009

Status Verified

September 1, 2009

Enrollment Period

6.9 years

First QC Date

November 9, 2005

Last Update Submit

September 30, 2009

Conditions

InfectionInflammationAdverse Effects

Keywords

complicationsadverse eventsregional anesthesiaadverse effects

Interventions

perineural block (anesthesia)PROCEDURE

continuous peripheral regional anesthesia ropivacaine 0.33% for 3 to 5 days

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients receiving perineural blocks via catheter ASA 1 to 4

You may qualify if:

  • All patients receiving perineural blocks via catheter

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BG Unfallklinik

Murnau am Staffelsee, Bavaria, 82418, Germany

Location

Related Publications (3)

  • 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.

    PMID: 16193317RESULT

  • 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.

    PMID: 17073856RESULT

  • Neuburger M, Reisig F, Zimmermann L, Buttner J. [Infection control in continuous peripheral regional anesthesia. Clinical study on disinfection time and subcutaneous tunneling in interscalene plexus anesthesia]. Anaesthesist. 2009 Aug;58(8):795-9. doi: 10.1007/s00101-009-1586-0. German.

    PMID: 19669706RESULT

MeSH Terms

Conditions

InfectionsInflammation

Interventions

Anesthesia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

  • Johannes Büttner, MD

    BG Unfallklinik Murnau

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 9, 2005

First Posted

November 10, 2005

Study Start

January 1, 2002

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

October 1, 2009

Record last verified: 2009-09

Locations

DE(1)