Neurologic Complications in Peripheral Regional Anesthesia - An Evaluation Based on a Standardized Protocol
Recruitment status was Active, not recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | March 7, 2007 | ||||
| Last Updated Date | May 5, 2008 | ||||
| Start Date ICMJE | May 2008 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00445016 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Neurologic Complications in Peripheral Regional Anesthesia - An Evaluation Based on a Standardized Protocol | ||||
| Official Title ICMJE | 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 | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients receiving peripheral regional anesthesia (routine) |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: peripheral regional anesthesia
evaluation and description of adverse effects |
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| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 1000 | ||||
| Estimated Completion Date | December 2008 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 10 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00445016 | ||||
| Other Study ID Numbers ICMJE | nd001 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Dr Michael Neuburger, BG Unfallklinik Murnau | ||||
| Study Sponsor ICMJE | BG Unfallklinik | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | BG Unfallklinik | ||||
| Verification Date | May 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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