A Comparison of Continuous Adductor Canal Catheter Infusion vs Continuous Femoral Nerve Catheter Infusion for Total Knee Replacement Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Timed Up Go (TUG) test
研究概览
简要总结
Open-labelled, randomised controlled trial. Patients will be assessed pre-operatively, at 24 and 48 hours for the primary outcome and secondary outcomes (except for Oxford Knee Score which will be assessed pre-operatively and at 6 months post-operatively by the ortho-paedic team).
Primary Objective: To demonstrate whether adductor canal nerve infusions result in superior patient mobilisation within the first 48 hours following total knee replacement compared to femoral nerve catheter infusions.
Secondary Objective: To identify whether adductor canal nerve infusions result in superior analgesia within the first 48 hours following total knee replacement compared to femoral nerve catheter infusions.
详细描述
We are comparing a continuous adductor canal block with a low concentration continuous femoral nerve block. We currently use a low dose femoral nerve catheter based technique as part of our standard treatment strategy for total knee arthroplasty. The use of a catheter provides prolonged analgesia compared to a single shot block, and also allows a lower concentration of local anaesthetic to be employed, thus potentially reducing the incidence of motor blockade. The concentration of local anaesthetic employed in our routine practice (0.0625% L- Bupivacaine) is lower than that routinely used in many other centres, and most clinical studies have compared higher concentrations of local anaesthetic - this might be expected to produce more motor blockade. The concentration we use is higher than the minimum effective concentration for a femoral catheter infusion for knee arthroplasty.
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has a diagnosis of rheumatoid or osteoarthritis and listed for a primary total knee replacement.
- •Participant is willing and able to give informed consent for participation in the study.
- •Male or Female, aged between 18 and 85 years.
- •American Society of Anesthesiologists (ASA) score I-III
- •Able (in the clinical staff's opinion) and willing to comply with all study requirements.
- •Willing to allow his or her General Practitioner and consultant, if appropriate, to be noti-fied of participation in the study.
排除标准
- •Patient refusal
- •Chronic pain (defined as consumption of >480mg codeine/24hrs or ANY regular strong opiate consumption by the oral/transdermal route)
- •Patients aged <18 or >85
- •ASA score >III
- •Body mass index (BMI) >35
- •Lacking mental capacity to give consent to enter trial/undergo surgery
- •Contraindications to catheter placement (coagulopathy , systemic sepsis or infection at placement site, pre-existing neuropathy) or any other component to the study treatment pathway.
- •Participant who is terminally ill
- •Allergy/intolerance to study medications
- •Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
结局指标
主要结局
Timed Up Go (TUG) test
时间窗: 48 hours post-op
This measures the time (in seconds) taken by a patient to rise to their feet from a sitting position, walk 3 metres in a straight line, turn around, walk back to the seat and sit down again.
次要结局
- Total opiate consumption(48 hours post-op)
- Maximum Voluntary Isometric Contraction (MVIC)(24 and 48 hours post-op)
- Visual Analogue Score (VAS) for pain(24 and 48 hours post-op)
- Range of knee flexion(24 and 48 hours post-op)
- Oxford Knee Score (OKS)(Pre-op, and at 6 months post-op)