Clinical Trials Directory

Trials / Terminated

TerminatedNCT02406300

Anesthesia And Post-operative Mortality After Proximal Femur Fractures

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
57 (actual)
Sponsor
Centro Hospitalar do Porto · Academic / Other
Sex
All
Age
60 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
PROCEDURESubarachnoid Anesthesia
PROCEDUREPNB/GA
DRUGropivacaine
DRUGsevoflurane or desflurane
DRUGbupivacaine or levobupivacaine

Timeline

Start date
2015-04-01
Primary completion
2016-12-31
Completion
2016-12-31
First posted
2015-04-02
Last updated
2021-02-01

Locations

1 site across 1 country: Portugal

Source: ClinicalTrials.gov record NCT02406300. Inclusion in this directory is not an endorsement.