An interventional study of Subarachnoid Anesthesia and PNB/GA in Hip Fractures, sponsored by Centro Hospitalar do Porto. Terminated at 1 site in Portugal. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2021-02-01.
Sponsored by Centro Hospitalar do Porto · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Patients submitted to subarachnoid anesthesia for proximal femur fracture surgical repair. Up to 12.5 mg of bupivacaine or levobupivacaine will be used
Procedure: Subarachnoid Anesthesia · Drug: bupivacaine or levobupivacaine
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
Procedure: PNB/GA · Drug: ropivacaine · Drug: sevoflurane or desflurane
Survival rate
Time frame: up to one year post-operative
Incidence of post-operative delirium
Measured with the 3D-CAM Questionaire (Confusion Assessment Method)
Time frame: Up to one week post-operative
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
Time frame: Up to one year post-operative
This study is terminated, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Centro Hospitalar do Porto