Anesthesia And Post-operative Mortality After Proximal Femur Fractures

Study Overview
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Brief Summary
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This study evaluates the effect of anesthesia on mortality after surgical repair of proximal femur fracture. Patients will receive either a subarachnoid block or a combination of peripheral nerve blocks and light general anesthesia (PNB/GA). The investigators hypothesis is that a combination of peripheral nerve blocks with an opioid free light anesthesia may have more favourable outcomes. Both groups will be followed up for assessment of post-operative morbidity and mortality.

Detailed Description
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Proximal femur fracture is one of the most common causes of admission in emergency departments. Mortality is high among these patients and is reported to range from 10% at 30 days, up to 32% at one-year post-operative. Several strategies to reduce mortality have been used, but mortality rate has plateaued since 1998. Attempts to show benefit from regional or general anesthesia have shown inconsistent results. New techniques with peripheral nerve blocks have been used, but their effect on mortality when used as major anesthesia component have not been studied. The investigators hypothesise that smaller physiologic impact of peripheral nerve blocks associated to light general anesthesia may improve survival rates and reduce short term delirium after proximal femur fracture surgery. Recovery of quality of life will also be assessed. Patients will be randomized into two groups, being allocated for a subarachnoid anesthesia or a combination of peripheral nerve blocks and light general anesthesia. Patients will be followed up for short-term post-operative complications such as incidence of delirium, recovery of quality of life and survival up to one year.

Official Title
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Contribution Of Anesthesia Technique For Post-operative Mortality Reduction After Proximal Femur Fractures Surgical Treatment - A Randomized Clinical Trial

Conditions
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Hip Fractures

Intervention / Treatment
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* Procedure: Subarachnoid Anesthesia
* Procedure: PNB/GA
* Drug: ropivacaine
* Drug: sevoflurane or desflurane
* Drug: bupivacaine or levobupivacaine


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Subarachnoid anesthesia<br>Patients submitted to subarachnoid anesthesia for proximal femur fracture surgical repair. Up to 12.5 mg of bupivacaine or levobupivacaine will be used | Procedure: Subarachnoid Anesthesia<br> <br> Drug: bupivacaine or levobupivacaine<br> <br> |
| Active Comparator: PNB/GA<br>Patients are submitted to a femoral, a lateral cutaneous nerve of the thigh and an anterior obturator nerve blocks with ropivacaine and an inhalational general anesthesia with sevoflurane or desflurane | Procedure: PNB/GA<br> <br> Drug: ropivacaine<br> <br> Drug: sevoflurane or desflurane<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate |  | up to one year post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of post-operative delirium | Measured with the 3D-CAM Questionaire (Confusion Assessment Method) | Up to one week post-operative | 
| Quality of Life Recovery | Quality of Life Assessment tools (SF12v2; EQ-5D (EuroQol); Post-operative Quality Recovery Scale) used from 30 days to one year post-operative. Comparing with pre-surgical values | Up to one year post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip Fracture, Regional Anesthesia, Peripheral Nerve Blocks, Post-operative Mortality, Cognitive Dysfunction, Quality of Life