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 |