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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 February 2021 |
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Main ID: |
NCT02406300 |
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Date of registration:
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30/03/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Anesthesia And Post-operative Mortality After Proximal Femur Fractures
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Scientific title:
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Contribution Of Anesthesia Technique For Post-operative Mortality Reduction After Proximal Femur Fractures Surgical Treatment - A Randomized Clinical Trial |
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Date of first enrolment:
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April 1, 2015 |
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Target sample size:
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57 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02406300 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Portugal
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Contacts
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Name:
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Fernando Abelha, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universidade do Porto |
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Name:
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Raul Carvalho, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Serviço de Anestesiologia, Centro Hospitalar do Porto; Faculdade de Medicina, Universidade do Porto |
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Name:
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Luís Azevedo, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universidade do Porto |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients admitted wiht a diagnosis of proximal femur fracture (ICD-9 codes 820.0 to
820.9) and submitted to surgical internal fixation of femur or hip prosthesis (ICD-9
codes 7935, 8151 and 8152)
Exclusion Criteria:
- Multiple fractures; polytrauma, active malignancy, ASA(American Society of Anesthesia)
status 5, antiplatelet drugs (other than aspirin) in the previous 5 days, known
allergies to local anesthetics, contra-indication to general or regional anesthesia
Age minimum:
60 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hip Fractures
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Intervention(s)
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Drug: ropivacaine
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Drug: sevoflurane or desflurane
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Procedure: PNB/GA
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Drug: bupivacaine or levobupivacaine
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Procedure: Subarachnoid Anesthesia
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Primary Outcome(s)
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Survival rate
[Time Frame: up to one year post-operative]
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Secondary Outcome(s)
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Quality of Life Recovery
[Time Frame: Up to one year post-operative]
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Incidence of post-operative delirium
[Time Frame: Up to one week post-operative]
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Secondary ID(s)
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226-14 (165-DEFI/193-CES)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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