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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02406300
Other study ID # 226-14 (165-DEFI/193-CES)
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date April 1, 2015
Est. completion date December 31, 2016

Study information

Verified date January 2021
Source Centro Hospitalar do Porto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Terminated
Enrollment 57
Est. completion date December 31, 2016
Est. primary completion date December 31, 2016
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Subarachnoid Anesthesia

PNB/GA

Drug:
ropivacaine

sevoflurane or desflurane

bupivacaine or levobupivacaine


Locations

Country Name City State
Portugal Serviço de Anestesiologia - Centro Hospitalar do Porto Porto

Sponsors (3)

Lead Sponsor Collaborator
Centro Hospitalar do Porto Center for Health Technology and Services Research, Universidade do Porto

Country where clinical trial is conducted

Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Primary Survival rate up to one year post-operative
Secondary Incidence of post-operative delirium Measured with the 3D-CAM Questionaire (Confusion Assessment Method) Up to one week post-operative
Secondary 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
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