Anesthesia And Post-operative Mortality After Proximal Femur Fractures

Hip Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02406300
• Other study ID #: 226-14 (165-DEFI/193-CES)
• Status: Terminated
• Phase: N/A
• Start date: April 1, 2015
• Est. completion date: December 31, 2016

Study information

• Verified date: January 2021
• Source: Centro Hospitalar do Porto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 57
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Femoral Fractures
• Fractures, Bone
• Hip Fractures

Intervention

Procedure:
• Subarachnoid Anesthesia

• PNB/GA

Drug:
• ropivacaine

• sevoflurane or desflurane

• bupivacaine or levobupivacaine

Locations

Country	Name	City	State
Portugal	Serviço de Anestesiologia - Centro Hospitalar do Porto	Porto

Sponsors (3)

Lead Sponsor	Collaborator
Centro Hospitalar do Porto	Center for Health Technology and Services Research, Universidade do Porto

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate		up to one year post-operative
Secondary	Incidence of post-operative delirium	Measured with the 3D-CAM Questionaire (Confusion Assessment Method)	Up to one week post-operative
Secondary	Quality of Life Recovery	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	Up to one year post-operative