Clinical trial NCT02406300: Anesthesia And Post-operative Mortality After Proximal Femur Fractures
Official title: Contribution Of Anesthesia Technique For Post-operative Mortality Reduction After Proximal Femur Fractures Surgical Treatment - A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hip Fractures
Keywords: Hip Fracture
Regional Anesthesia
Peripheral Nerve Blocks
Post-operative Mortality
Cognitive Dysfunction
Quality of Life
Lead sponsor: Centro Hospitalar do Porto
Sponsor class: OTHER
Collaborators: name: Center for Health Technology and Services Research
name: Universidade do Porto
First posted: 2015-04-02
Enrollment: 57
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Survival rate
timeFrame: up to one year post-operative
Secondary outcomes:
measure: Incidence of post-operative delirium
timeFrame: Up to one week post-operative
measure: Quality of Life Recovery
timeFrame: Up to one year post-operative
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Serviço de Anestesiologia - Centro Hospitalar do Porto
Study officials:
affiliation: Serviço de Anestesiologia, Centro Hospitalar do Porto; Faculdade de Medicina, Universidade do Porto
name: Raul Carvalho, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade do Porto
name: Luís Azevedo, PhD
role: STUDY_CHAIR
affiliation: Universidade do Porto
name: Fernando Abelha, PhD
role: STUDY_CHAIR
References:
citation: Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.