Surgical Techniques in Arthroplasty of the Knee (STArK) 1 Trial
Research type
Research Study
Full title
Surgical Techniques in Arthroplasty of the Knee (STArK) 1 Trial: Periarticular infiltration versus Intra-articular injection for postoperative analgesia in primary total knee arthroplasty: a randomised double blind controlled trial
IRAS ID
241807
Contact name
Chloe Scott
Contact email
Sponsor organisation
NHS Lothian
Clinicaltrials.gov Identifier
Duration of Study in the UK
10 years, 6 months, 0 days
Research summary
Study Background
Osteoarthritis of the knee is a common degenerative musculoskeletal condition which affects nearly five million people in the United Kingdom. Some patients will require total knee replacement surgery if their symptoms of pain and disability are not controlled adequately by so-called ‘conservative’ measures such as weight-loss, activity modification and analgesic (pain-killer) medication.Over the past ten years our understanding of pain-relief strategies during total knee replacement, often termed ‘Enhanced Recovery’ principles, has helped improve patient care and reduced length of hospital admission. ‘Enhanced Recovery’ principles recommend the use of analgesic medications which can be delivered in a variety of ways e.g.. tablets and injections. This is termed ‘multi-modal’ analgesia.
Prior to total knee replacement, the patient will receive an injection around the nerves in the spine (regional anaesthesia) which numbs the patient from the waist down and allows the surgeon to perform the operation in a safe and pain-free manner. During the operation, surgeons often choose to deliver extra local anaesthetic to prolong the degree of pain-relief in the immediate post-operative period. This can enable patients to mobilise early and is associated with greater long-term satisfaction.
There are two main methods of delivering this extra form of pain-relief during the operation. Peri-articular injection involves multiple injections of local anaesthetic into the soft-tissues surround the knee. In contrast, Intra-articular injection involves a single injection directly into the knee joint once the operation is finished. Currently, there is no clear evidence available to Orthopaedic surgeons to inform us which technique is better at providing pain relief for patients undergoing total knee replacement surgery.
All patients undergoing total knee replacement surgery for osteoarthritis of the knee will be invited to participate in this study. We intend to recruit a total of 120 patients. During the patient’s total knee replacement surgery, they shall receive an injection of local anaesthetic around the soft-tissues of the knee (Peri-Articular Injection) or directly into the knee joint itself (Intra-Articular Injection). The decision regarding which treatment they receive is decided entirely by randomisation.
Following the operation, a member of the research team will visit the patient on the ward to collect information regarding levels of pain and overall satisfaction. The type of injection received shall be kept secret from both the patient, and the member of the research team collecting the post-operative pain scores.
After the patient has been safely discharged from hospital, we intend to follow-up all participants for one year. This will involve routine clinic appointments at six weeks and twelve months following surgery. This will involve review and clinical examination by a member of the orthopaedic team who have treated the patient whilst in hospital and/or a member of the research team.
In addition, all patients will be asked to complete a questionnaire at twelve months regarding their level of function and pain. These questionnaires have been used widely in the medical literature and have a strong evidence base for their use.
What is the aim of this study?
The aim of this study is compare the amount of pain relief provided by two different methods of local anaesthetic injection techniques used in total knee replacement surgery. In addition, we would like to know if this influences the patient’s immediate and long-term recovery after surgery.REC name
South East Scotland REC 01
REC reference
19/SS/0008
Date of REC Opinion
16 Jan 2019
REC opinion
Favourable Opinion