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. 2017 May 11;2017(5):CD001159. doi: 10.1002/14651858.CD001159.pub2

NCT02406300.

Trial name or title Contribution of anaesthesia technique for post‐operative mortality reduction after proximal femur fractures surgical treatment ‐ a randomized clinical trial
Methods Parallel RCT
Double‐blind (investigator, outcome assessor)
Participants Inclusion criteria: adults (≥ 60 years) admitted with 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 physical status V, antiplatelet drugs (other than aspirin) in previous 5 days, known allergies to local anaesthetics, contraindication to general or regional anaesthesia
Interventions Treatment group: femoral, lateral cutaneous nerve of the thigh and anterior obturator nerve blocks with ropivacaine and inhalational general anaesthesia with sevoflurane or desflurane
Control group: spinal anaesthesia with bupivacaine
Outcomes Primary outcome measures: survival rate up to 1 year after surgery
Secondary outcome measures: incidence of postoperative delirium (up to 1 week postoperatively and measured with the 3D‐CAM Questionnaire (Confusion Assessment Method)), quality of life recovery (measured by quality of life assessment tools (SF12v2; EQ‐5D (EuroQol) at 30 days and 1 year after surgery)
Starting date April 2015
Contact information Raul Carvalho, MD, MSc, Centro Hospitalar do Porto
Notes Enrolling