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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02406300

Enrollment

Registered

2015-04-02

Start date

2015-04-01

Completion date

2016-12-31

Last updated

2021-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Fractures

Keywords

Hip Fracture, Regional Anesthesia, Peripheral Nerve Blocks, Post-operative Mortality, Cognitive Dysfunction, Quality of Life

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.

Interventions

PROCEDURESubarachnoid Anesthesia

PROCEDUREPNB/GA

DRUGropivacaine

DRUGsevoflurane or desflurane

DRUGbupivacaine or levobupivacaine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Survival rate	up to one year post-operative

Secondary

Measure	Time frame	Description
Incidence of post-operative delirium	Up to one week post-operative	Measured with the 3D-CAM Questionaire (Confusion Assessment Method)
Quality of Life Recovery	Up to one year post-operative	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

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026