Trial Status - Open to Recruitment
Study of Peri-Articular Anaesthetic for Replacement of the Knee
Knee replacement is highly successful for treating moderate to severe arthritis that has failed non operative treatment, however the surgery is painful and nearly half of patients report severe pain postoperatively. If pain is not controlled, it slows recovery and can lead to complications such as chest infection, heart attack, and blood-clots. In addition, experiencing pain after surgery leads to longer hospital stays and patient dissatisfaction.
Following knee replacement, the pain is worst over the first 72 hours with pain control provided by a combination of tablets and local anaesthetic (LA) injected around the knee. The duration of current LAs is limited to around 12 to 24 hours with patients often getting significant breakthrough pain the morning following surgery when the LA has worn off and they are encouraged to start physiotherapy.
A new formulation of LA, liposomal bupivacaine, has been widely used in the USA since 2011 but is not yet licensed in the UK. It is reported to give pain relief over 72 hours and across a range of surgeries has been reported to improve pain control, reduce the need for additional pain killers and result in a shorter hospital stays compared to current LAs.
This SPAARK study has been designed to assess the clinical and cost effectiveness of liposomal bupivacaine compared with bupivacaine hydrochloride (current LA) for postoperative recovery following knee replacement.
We aim to investigate:
- Whether liposomal bupivacaine improves pain and recovery following knee replacement in the short term
- Whether any short term gains translate into long term patient reported functional benefits
- Whether the use of liposomal bupivacaine is cost effective as part of a multi-modal enhanced recovery protocol within the NHS.
This is a multicentre randomised controlled trial taking place in 5 hospitals across the UK and will recruit 500 patients.