Complications and Adverse Effects in Continuous Peripheral Regional Anesthesia

Inflammation Clinical Trial

Official title:

Complications and Adverse Effects in Continuous Peripheral Regional Anesthesia Results of Investigations on 3,491 Catheters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00251654
• Other study ID #: MRA001
• Status: Completed
• Phase: Phase 4
• First received: November 9, 2005
• Last updated: September 30, 2009
• Start date: January 2002
• Est. completion date: December 2008

Study information

• Verified date: September 2009
• Source: Rechbergklinik Bretten
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9000
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year and older

Eligibility

Inclusion Criteria:

• All patients receiving perineural blocks via catheter

Exclusion criteria:

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Adverse Effects
• Infection
• Inflammation

Intervention

Procedure:
• perineural block (anesthesia)
continuous peripheral regional anesthesia ropivacaine 0.33% for 3 to 5 days

Locations

Country	Name	City	State
Germany	BG Unfallklinik	Murnau	Bayern

Sponsors (2)

Lead Sponsor	Collaborator
Rechbergklinik Bretten	Unfallklinik Murnau

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Neuburger M, Breitbarth J, Reisig F, Lang D, Büttner J. [Complications and adverse events in continuous peripheral regional anesthesia Results of investigations on 3,491 catheters]. Anaesthesist. 2006 Jan;55(1):33-40. German. — View Citation

Neuburger M, Büttner 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. Epub 2006 Nov 1. — View Citation

Neuburger M, Reisig F, Zimmermann L, Büttner 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 — View Citation