Anesthesia And Post-operative Mortality After Proximal Femur Fractures

Not Applicable

Terminated

• Conditions: Hip Fractures
• Interventions: Procedure: PNB/GA; Procedure: Subarachnoid Anesthesia; Drug: bupivacaine or levobupivacaine; Drug: ropivacaine; Drug: sevoflurane or desflurane

• Registration Number: NCT02406300
• Lead Sponsor: Centro Hospitalar do Porto

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.

Study Timeline

• Study First Submitted: 2015-03-30
• Study Start: 2015-04-01
• Study First Submitted QC: 2015-04-01
• Study First Posted: 2015-04-02
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-27
• Last Update Posted: 2021-02-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 57

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PNB/GA	sevoflurane or desflurane	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
PNB/GA	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
Subarachnoid anesthesia	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
Subarachnoid anesthesia	bupivacaine or levobupivacaine	Patients submitted to subarachnoid anesthesia for proximal femur fracture surgical repair. Up to 12.5 mg of bupivacaine or levobupivacaine will be used
PNB/GA	ropivacaine	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

Primary Outcome Measures

Name	Time	Method
Survival rate	up to one year post-operative

Secondary Outcome Measures

Name	Time	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
Incidence of post-operative delirium	Up to one week post-operative	Measured with the 3D-CAM Questionaire (Confusion Assessment Method)

Trial Locations

Locations (1)

Serviço de Anestesiologia - Centro Hospitalar do Porto; 🇵🇹 Porto, Portugal