The effect of local anaesthetic wound infiltration on @entity1118 after lower limb joint replacement: a protocol for a double-blind XXXX .

@entity1 @entity390 @entity571 @entity391 @entity23 @entity1341 @entity158 @entity1118
BACKGROUND: For the majority of @entity1 with @entity571 ( @entity571 ), joint replacement is a successful intervention for relieving chronic @entity158 . However, between 10-30% of @entity1 continue to experience @entity1118 after joint replacement. Evidence suggests that a risk factor for @entity1118 after joint replacement is the severity of acute post-operative @entity158 . The aim of this @entity23 ( @entity23 ) is to determine if intra-operative local anaesthetic wound infiltration additional to a standard anaesthesia regimen can reduce the severity of @entity158 at 12-months after total knee replacement (TKR) and total hip replacement (THR) for @entity571 . METHODS: 300 TKR @entity1 and 300 THR @entity1 are being recruited into this single-centre double-blind @entity23 . @entity1 are recruited before surgery and randomised to either the standard care group or the intervention group. @entity1 and outcome assessors are blind to treatment allocation throughout the study. The intervention consists of an intra-operative local anaesthetic wound infiltration, consisting of 60 mls of 0.25% @entity1341 with 1 in 200,000 adrenaline. @entity1 are assessed on the first 5 days post-operative, and then at 3-months, 6-months and 12-months. The primary outcome is the WOMAC @entity158 Scale, a validated measure of @entity158 at 12-months. Secondary outcomes include @entity158 severity during the in- @entity1 stay, post-operative @entity390 and @entity391 , satisfaction with @entity158 relief, length of hospital stay, @entity158 and disability, @entity158 sensitivity, complications and cost-effectiveness. A nested qualitative study within the @entity23 will examine the acceptability and feasibility of the intervention for both @entity1 and healthcare professionals. DISCUSSION: Large-scale RCTs assessing the effectiveness of a surgical intervention are uncommon, particularly in orthopaedics. The results from this trial will inform evidence-based recommendations for both short-term and long-term @entity158 management after lower limb joint replacement. If a local anaesthetic wound infiltration is found to be an effective and cost-effective intervention, implementation into clinical practice could improve long-term @entity158 outcomes for @entity1 undergoing lower limb joint replacement. TRIAL REGISTRATION: Current Controlled Trials ISRCTN96095682.
