Neurologic Complications in Peripheral Regional Anesthesia - An Evaluation Based on a Standardized Protocol

May 5, 2008 updated by: BG Unfallklinik

Neurologic Complications in Peripheral Regional Anesthesia - A Clinical Follow Up Study to Evaluate the Incidence of Neurologic Complications Defined According to a Standardized Protocol Considering Motoric and Sensory Function and Pain

To evaluate the incidence of neurologic complications as a consequence of peripheral regional anesthesia, all patients receiving peripheral nerve blocks will be evaluated according to a standardized protocol screening pain, motoric and sensory function recovering to defined periods, and according to a study protocol defining the items.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Neurologic complications as an adverse effect occur in all types of regional anesthesia. Reviewing the literature, the incidence spreads from 0.02 up to 3 percent. The incidence remains unclear because of different types of definitions, too. In this study, we evaluate all patients receiving peripheral regional anesthesia 24 hours after block performance according to a standardized study protocol. In case of any conspicuousness concerning motoric or sensory function or pain, the patient will be evaluated again after 48 hours. Further on, in case of neurologic dysfunction, periods of investigation will be after 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months and 1 year. This study includes the definition for nerve damage concerning motoric and sensory neural function and pain.

The patients will be recruited among all patients from our hospital receiving continuous peripheral regional anesthesia.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bayern
      • Murnau, Bayern, Germany, 82418
        • BG Unfallklinik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients receiving peripheral regional anesthesia (routine)

Description

Inclusion Criteria:

  • All patients receiving peripheral regional anesthesia

Exclusion Criteria:

  • Missing agreement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BG Unfallklinik

Investigators

  • Study Chair: Johannes Buettner, MD, BG Unfallklinik Murnau

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Study Completion (Anticipated)

December 1, 2008

Study Registration Dates

First Submitted

March 7, 2007

First Submitted That Met QC Criteria

March 7, 2007

First Posted (Estimate)

March 8, 2007

Study Record Updates

Last Update Posted (Estimate)

May 9, 2008

Last Update Submitted That Met QC Criteria

May 5, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ND001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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