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Complications and Adverse Effects in Continuous Peripheral Regional Anesthesia

This study has been completed.
Sponsor:
Collaborator:
Unfallklinik Murnau
Information provided by:
Rechbergklinik Bretten
ClinicalTrials.gov Identifier:
NCT00251654
First received: November 9, 2005
Last updated: September 30, 2009
Last verified: September 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Infection
Inflammation
Adverse Effects
 Procedure: perineural block (anesthesia)
 Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Complications and Adverse Effects in Continuous Peripheral Regional Anesthesia Results of Investigations on 3,491 Catheters

Further study details as provided by Rechbergklinik Bretten:

Enrollment: 9000
Study Start Date: January 2002
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: perineural block (anesthesia)
    continuous peripheral regional anesthesia ropivacaine 0.33% for 3 to 5 days
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.

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients receiving perineural blocks via catheter ASA 1 to 4

Criteria

Inclusion Criteria:

  • All patients receiving perineural blocks via catheter

Exclusion criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00251654

Locations
Germany
BG Unfallklinik
Murnau, Bayern, Germany, 82418
Sponsors and Collaborators
Rechbergklinik Bretten
Unfallklinik Murnau
Investigators
Study Chair: Johannes Büttner, MD Unfallklinik Murnau
  More Information

Publications:

Responsible Party: Dr. M. Neuburger, OrtenauKlinikum Achern
ClinicalTrials.gov Identifier: NCT00251654     History of Changes
Other Study ID Numbers: MRA001
Study First Received: November 9, 2005
Last Updated: September 30, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Rechbergklinik Bretten:
complications
adverse events
regional anesthesia
adverse effects

Additional relevant MeSH terms:
Iatrogenic Disease
Drug Toxicity
Inflammation
Disease Attributes
Pathologic Processes
Poisoning
Substance-Related Disorders
 Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013