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

Sponsored by:	BG Unfallklinik
Information provided by:	BG Unfallklinik
ClinicalTrials.gov Identifier:	NCT00445016

Purpose

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	Intervention
Anesthesia, Conduction Nerve Block Adverse Effects	Procedure: peripheral regional anesthesia

MedlinePlus related topics: Anesthesia

U.S. FDA Resources

Study Type:	Observational
Study Design:	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

Further study details as provided by BG Unfallklinik:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	1000
Study Start Date:	May 2008
Estimated Study Completion Date:	December 2008

Intervention Details:

evaluation and description of adverse effects

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.

Eligibility

Ages Eligible for Study:	10 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Patients receiving peripheral regional anesthesia (routine)

Criteria

Inclusion Criteria:

All patients receiving peripheral regional anesthesia

Exclusion Criteria:

Missing agreement

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445016

Locations

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

Sponsors and Collaborators

BG Unfallklinik

Investigators

Study Chair:

Johannes Buettner, MD

BG Unfallklinik Murnau

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	BG Unfallklinik Murnau ( Dr Michael Neuburger )
Study ID Numbers:	nd001
Study First Received:	March 7, 2007
Last Updated:	May 5, 2008
ClinicalTrials.gov Identifier:	NCT00445016 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by BG Unfallklinik:

peripheral regional anesthesia
nerve damage
adverse effects
neurologic complication
neuropathy

Study placed in the following topic categories:

Central Nervous System Depressants
Anesthetics
Pain

Additional relevant MeSH terms:

Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants

Anesthetics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009