REGARD feasibility study
Research type
Research Study
Full title
A Feasibility Randomised Controlled Trial to compare REgional versus General Anaesthesia in Reducing Delirium in patients with Hip Fractures (REGARD)
IRAS ID
227966
Contact name
Joyce Yeung
Contact email
Sponsor organisation
University of Warwick
Duration of Study in the UK
1 years, 4 months, 0 days
Research summary
Patients who fall and sustain hip fractures are older and sometimes suffer from several health problems. Previous studies have shown that whilst some return to their previous quality of life, other patients do not recover well. For example some patients experience poor memory, feeling physically weak or they are not able to be as independent as they were before they fractured their hip. Patients who do not recover well have higher risk of developing complications after their operation. All patients undergoing surgery for hip fracture will be provided with anaesthesia. This research study is comparing the use of two standard types of anaesthetic (general anaesthesia – when you are unconscious, regional anaesthesia – when you have nerve block and lightly sedated) for patients undergoing surgery for hip fractures. Research is needed to understand whether the type of anaesthesia may affect how well patients recover after surgery. This research study aims to find out if it is feasible to carry out a trial comparing the two types of anaesthesia in patients undergoing surgery for hip fracture. To find out whether one type of anaesthesia is better, a large number of participants would be needed which would be very expensive. By carrying out this smaller scale study first, we will know whether it is possible to complete a larger study. There are some suggestions that patients given regional anaesthesia may recover better but this has not been thoroughly tested. We do not currently know whether one type of anaesthesia is better than the other.
Lay summary of study results: Patients who fall and sustain hip fractures are older and sometimes suffer from several health problems. Previous studies have shown that whilst some return to their previous quality of life, other patients do not recover well. One of the complications is delirium or acute confusion. This happens when a person has a rapid deterioration in their mental functioning often becoming agitated or drowsy. Delirium can affect how well patients recover after hip fracture surgery. There is some research that suggest avoiding general anaesthesia for hip fracture surgery may reduce the risk of delirium.
A Feasibility Randomised Controlled Trial to compare REgional versus General Anaesthesia in Reducing Delirium in patients with Hip Fractures (REGARD) was a study to test whether it is possible to use a computer to decide whether patients receive general anaesthesia (GA, where patient is asleep) or a regional anaesthetic (RA, where lower part of the body is numb but patients are not fully asleep) and we followed up patients during their recovery.
Four NHS hospitals took part in REGARD study. 100 of 283 eligible patients (35.3%) were recruited. Fifty patients received GA and 48 received RA. Delirium was diagnosed in 19/70 (27.1%), 14/46 (30.5%) and 16/60 (26.7%) on Day 1, 2 and 7 post surgery. Overall 46 patients (56.8%) completed 120 day follow-up.
Our results showed that a larger study to examine the impact of GA versus RA on incidence of delirium in the post-operative period and up to 120 days is feasible.
REC name
London - South East Research Ethics Committee
REC reference
17/LO/1156
Date of REC Opinion
27 Jul 2017
REC opinion
Favourable Opinion