ISRCTN46653818.
Trial name or title | Femoral nerve blockade in hip fracture patients |
Methods | RCT Approved by the ethics committee Funding: governmental: Umeå University (Sweden) |
Participants | Target number of participants: 250 Inclusion criteria: both males and females, aged 70 years and above, all hip fracture patients admitted to the orthopaedic department Exclusion criteria: local infection, allergy to local anaesthesia, dying patients, pathologic hip fractures |
Interventions |
Treatment group: Participants in the intervention group will receive a femoral nerve blockade as soon as they arrive. Participants with pain scores > 4 will be given morphine IV according to the standard protocol (morphine 10 mg/mL, 1 to 5 mg when necessary) Control group: regular use of opioids Both groups will receive 1 G of paracetamol 4 times/d. Postoperative pain treatment will be given according to the standard protocol in both arms of the study. Total follow‐up for both arms will end at the time of discharge |
Outcomes | Primary outcome measures: postoperative delirium, assessed 3 times a day; postoperative complications, such as decubital ulcers, infections, thrombosis, heart failure and pain. A cognitive test will be assessed in the ambulance pre‐hospital arrival and at 24 +/‐ 6 hours postoperatively. At days three to five, a more thorough assessment will be done including delirium, depression, cognitive status, quality of life and more Secondary outcome measures: mortality, orthopaedic recovery recorded at the time of discharge from the hospital, EQ‐5D, economics |
Starting date | 30/03/2009 |
Contact information | Prof Ola Winso Operationscentrum Norrlands universitetssjukhus Umea SE‐901 85 Sweden |
Notes | Completed http://www.umu.se/umu/index_eng.html |