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
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change in pain levels during first 48 hours after surgery.
研究概览
简要总结
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 assess 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.
详细描述
The aim of this study is compare the amount of post-operative pain relief provided by two different methods of local anaesthetic injection techniques used in total knee replacement surgery.
'Enhanced Recovery After Surgery' protocols has significantly shortened recovery-time and length of hospital admission after total knee replacement (TKR). A major factor in this improvement has been the incorporation of multi- modal therapies which deliver adequate pain relief, limit post-operative nausea and enable early mobilisation.
Peripheral nerve blocks are performed by the anaesthetist immediately prior to surgery. This involves injecting local anaesthetic around the nerves which supply sensation around the knee. Injecting directly into the nerve can damage it and lead to significant disability. For this reason peripheral nerve blocks are often performed under ultrasound guidance. This can be time-consuming and does not negate the risk of nerve injury.
Peri-articular infiltration is performed during the operation by the surgeon. In the knee this involves injecting a solution of local anaesthetic into multiple specified soft-tissue and bony regions around the knee. It is performed blind without ultrasound guidance and also carries risk of nerve injury.
Intra-articular injections involve the surgeon injecting local anaesthetic solution into the knee joint itself. During TKR, this can be performed after closure of the joint capsule immediately prior to skin closure. This avoids risks to nerves and arteries as it is placed into the large knee joint, and not blindly around the joint capsule. In addition, it is simple to perform and less time-consuming than peri-articular infiltration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary knee osteoarthritis requiring Total Knee Replacement surgery
- •Planned for cruciate retaining prosthesis without patella resurfacing
- •Patient is able to give informed consent
- •Patient resides locally and will be available for follow up
排除标准
- •Inflammatory arthropathy
- •Preoperative morphine based analgesia
- •Renal insufficiency (GFR<30)
- •Allergy to study drugs
- •Spinal anaesthetic not possible
- •Neurological disorder affecting the lower limbs
研究组 & 干预措施
Treatment group 1: Periarticular infiltration
Patients undergoing total knee replacement who are randomised to Treatment Group 1.
干预措施: Periarticular infiltration (Procedure)
Treatment Group 2: Intra-articular infiltration
Patients undergoing total knee replacement who are randomised to Treatment Group 2.
干预措施: Intra-articular infiltration (Procedure)
结局指标
主要结局
Change in pain levels during first 48 hours after surgery.
时间窗: Pre-operative baseline and then re-checked at intervals in post-operative period 6, 12, 24 and 48 hours
The Visual Analogue Score (VAS) for pain is a well recognised and validated measure of postoperative pain and has been used as a primary outcome measure on other studies comparing analgesic methods at Total Knee Replacement
次要结局
- Opiate use first 24 hours(24 hours)
- Length of hospital stay(Through study completion, at 12 months post-operation.)
- Patient Satisfaction(Through study completion, at 12 months post-operation.)
- Change in Oxford Knee Score at 12 months after surgery.(12 months)
研究者
Chloe Scott
Consultant Orthopaedic Surgeon
Royal Infirmary of Edinburgh