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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00445016
Recruitment Status : Unknown
Verified May 2008 by BG Unfallklinik.
Recruitment status was:  Active, not recruiting
First Posted : March 8, 2007
Last Update Posted : May 9, 2008
Information provided by:
BG Unfallklinik

Brief Summary:
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.

Condition or disease Intervention/treatment
Anesthesia, Conduction Nerve Block Adverse Effects Procedure: peripheral regional anesthesia

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
Estimated Enrollment : 1000 participants
Time Perspective: Prospective
Official Title: 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
Study Start Date : May 2008
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia

Intervention Details:
  • Procedure: peripheral regional anesthesia
    evaluation and description of adverse effects

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients receiving peripheral regional anesthesia (routine)

Inclusion Criteria:

  • All patients receiving peripheral regional anesthesia

Exclusion Criteria:

  • Missing agreement

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00445016

BG Unfallklinik
Murnau, Bayern, Germany, 82418
Sponsors and Collaborators
BG Unfallklinik
Study Chair: Johannes Buettner, MD BG Unfallklinik Murnau

Additional Information:
Responsible Party: Dr Michael Neuburger, BG Unfallklinik Murnau Identifier: NCT00445016     History of Changes
Other Study ID Numbers: nd001
First Posted: March 8, 2007    Key Record Dates
Last Update Posted: May 9, 2008
Last Verified: May 2008

Keywords provided by BG Unfallklinik:
peripheral regional anesthesia
nerve damage
adverse effects
neurologic complication

Additional relevant MeSH terms:
Central Nervous System Depressants
Physiological Effects of Drugs