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Sponsored by: |
BG Unfallklinik |
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Information provided by: | BG Unfallklinik |
ClinicalTrials.gov Identifier: | NCT00445016 |
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 |
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Anesthesia, Conduction Nerve Block Adverse Effects |
Procedure: peripheral regional anesthesia |
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 |
Estimated Enrollment: | 1000 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | December 2008 |
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.
Ages Eligible for Study: | 10 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Patients receiving peripheral regional anesthesia (routine)
Inclusion Criteria:
Exclusion Criteria:
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 |
peripheral regional anesthesia nerve damage adverse effects neurologic complication neuropathy |
Central Nervous System Depressants Anesthetics Pain |
Therapeutic Uses Physiological Effects of Drugs Central Nervous System Depressants |
Anesthetics Central Nervous System Agents Pharmacologic Actions |