Anesthesia And Post-operative Mortality After Proximal Femur Fractures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-01

Study Completion Date

2016-12-31

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.

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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.

Conditions

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Hip Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Subarachnoid anesthesia

Patients submitted to subarachnoid anesthesia for proximal femur fracture surgical repair.

Up to 12.5 mg of bupivacaine or levobupivacaine will be used

Group Type ACTIVE_COMPARATOR

Subarachnoid Anesthesia

Intervention Type PROCEDURE

bupivacaine or levobupivacaine

Intervention Type DRUG

PNB/GA

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

Group Type ACTIVE_COMPARATOR

PNB/GA

Intervention Type PROCEDURE

ropivacaine

Intervention Type DRUG

sevoflurane or desflurane

Intervention Type DRUG

Interventions

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Subarachnoid Anesthesia

Intervention Type PROCEDURE

PNB/GA

Intervention Type PROCEDURE

ropivacaine

Intervention Type DRUG

sevoflurane or desflurane

Intervention Type DRUG

bupivacaine or levobupivacaine

Intervention Type DRUG

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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No