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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by BG Unfallklinik.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
BG Unfallklinik
ClinicalTrials.gov Identifier:
NCT00445016
First received: March 7, 2007
Last updated: May 5, 2008
Last verified: May 2008
  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

Study Type: Observational
Study Design: 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

Further study details as provided by BG Unfallklinik:

Estimated Enrollment: 1000
Study Start Date: May 2008
Estimated Study Completion Date: December 2008
Intervention Details:
    Procedure: peripheral regional anesthesia
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
No publications provided

Responsible Party: Dr Michael Neuburger, BG Unfallklinik Murnau
ClinicalTrials.gov Identifier: NCT00445016     History of Changes
Other Study ID Numbers: nd001
Study First Received: March 7, 2007
Last Updated: May 5, 2008
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

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014