Can Periarticular Knee Injection of Multimodal Agents Levobupivicaine, Morphine, Ketorolac and Adrenaline Improve Postoperative Pain and Function Following Primary Total Knee Arthroplasty?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale
研究概览
简要总结
Peri-articular knee infiltration with Levobupivicaine 150mg, Morphine 10mg and Ketorolac 30mg reduces postoperative pain following primary total knee replacement compared with the current standard treatment of femoral nerve blockade.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing an elective primary unilateral total knee arthroplasty (TKA) under the care of an orthopaedic consultant at University Hospitals Coventry and Warwickshire NHS trust are potentially eligible for the trial.
排除标准
- •Those with sufficient cognitive impairment that they would be unable complete questionnaire (cognitive impairment).
- •Those patients who lack capacity under the Mental Capacity Act 2005
- •Those patients with a pre-operative history of neurological abnormality in the ipsilateral leg e.g. history of stroke, neurogenic pain or previous nerve injury.
- •Those patients having spinal anaesthesia.
- •Those patients with a specific contraindication to the analgesic agents used:Morphine: Hypersensitivity reaction Ketorolac: Active or previous peptic ulcer. History of upper gastrointestinal bleeding or perforation, related to previous NSAID therapy.
- •Haemorrhagic diatheses, including coagulation disorders
- •Hypersensitivity to ketorolac trometamol or other NSAIDs
- •Moderate or severe renal impairment (serum creatinine > 160 micromol/l)
- •Levobupivicaine: Levobupivacaine solutions are contra-indicated in patients with a known hypersensitivity to levobupivacaine, local anaesthetics of the amide type or any of the excipients
- •Uncontrolled angina
- •2nd/ 3rd degree heart block
研究组 & 干预措施
Femoral Nerve Block
levobupivacaine
干预措施: Femoral Nerve Block (Drug)
peri-articular infiltration
The peri-articular infiltration of multimodal agents will consist of 150 mg of levobupivacaine, 10 mg morphine and 30mg ketorolac diluted in 0.9% saline to make a volume 100 ml. (0.5ml 1:1000 adrenaline will be added to the mixture to reduce blood loss after the operation) Fifty ml of the mixture will be injected into the posterior, medial and lateral soft-tissues just prior to implantation of the TKA components. Care will be taken to avoid excessive infiltration in the area of the common peroneal nerve. Then, while the cement is curing, the anterior soft-tissues including the quadriceps mechanism, the retinacular tissues and the subcuticular tissues will be infiltrated with the remaining 50 ml of peri-articular injection.
干预措施: peri-articular infiltration (Drug)
结局指标
主要结局
Visual Analogue Scale
时间窗: 18 Hours post operatively
A validated, patient-reported 100 mm visual analogue pain score. It is a line 100mm long on which patient places a line through to mark the severity of the pain the patient is experiencing from 0mm= No pain to 100mm wost pain possible.
次要结局
- 4 point pain score(First 48 hours post surgery)
- Analgesia required(48 hour period post operativley)
- Concentration of Levobupivicaine in drain and patient serum samples(6 hours post operation and pre and post retransfusion)
- Functional Assessments change over time 18, 48 & 6 weeks(18 & 48 Hours and 6 weeks post surgery)
研究者
Matthew Costa
Professor of Trauma and Orthopaedic Surgery
University of Warwick