Abstract
BackgroundFor the majority of patients with osteoarthritis (OA), joint replacement is a successful intervention for relieving chronic joint pain. However, between 10-30% of patients continue to experience chronic pain after joint replacement. Evidence suggests that a risk factor for chronic pain after joint replacement is the severity of acute post-operative pain. The aim of this randomised controlled trial (RCT) is to determine if intra-operative local anaesthethic wound infiltration additional to a standard anaethesia regimen can reduce the severity of joint pain at 12-months after total knee replacement (TKR) and total hip replacement (THR) for OA.Methods300 TKR patients and 300 THR patients are being recruited into this single-centre double-blind RCT. Participants are recruited before surgery and randomised to either the standard care group or the intervention group. Participants 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% bupivacaine with 1 in 200,000 adrenaline. Participants 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 Pain Scale, a validated measure of joint pain at 12-months. Secondary outcomes include pain severity during the in-patient stay, post-operative nausea and vomiting, satisfaction with pain relief, length of hospital stay, joint pain and disability, pain sensitivity, complications and cost-effectiveness. A nested qualitative study within the RCT will examine the acceptability and feasibility of the intervention for both patients and healthcare professionals.DiscussionLarge-scale RCTs assessing the effectiveness of a surgical intervention are uncommon, particulary in orthopaedics. The results from this trial will inform evidence-based recommendations for both short-term and long-term pain 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 pain outcomes for patients undergoing lower limb joint replacement.Trial registrationCurrent Controlled Trials ISRCTN96095682
Highlights
For the majority of patients with osteoarthritis (OA), joint replacement is a successful intervention for relieving chronic joint pain
Chronic pain after surgery is defined by the International Association for the Study of Pain (IASP) as pain that develops after a surgical intervention and is of at least 3-months duration [5]
For patients undergoing joint replacement, chronic pain can be distressing because the main reason for electing to undergo surgery is to gain relief from chronic joint pain
Summary
For the majority of patients with osteoarthritis (OA), joint replacement is a successful intervention for relieving chronic joint pain. Evidence suggests that a risk factor for chronic pain after joint replacement is the severity of acute post-operative pain. The aim of this randomised controlled trial (RCT) is to determine if intra-operative local anaesthethic wound infiltration additional to a standard anaethesia regimen can reduce the severity of joint pain at 12-months after total knee replacement (TKR) and total hip replacement (THR) for OA. Research evidence suggests that an important risk factor for chronic pain after surgery is the severity of acute post-operative pain [9,10]. Adequate management of post-operative pain still poses a significant challenge to healthcare, as demonstrated by a review of the literature which concluded that 30% of patients experience moderate or severe pain after surgery [11]. There is a need for trials of interventions targeting acute postoperative pain with the ultimate aim of improving longterm outcomes after joint replacement
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