A Randomised Single Blind Study Comparing the Molar Median Effective Dose of Levobupivacaine and Molar Median Effective Dose of Ropivacaine When Administered as a Femoral Perineural Infusion for Pain Relief After Total Knee Replacement
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- NHS Tayside
- 入组人数
- 14
- 主要终点
- Pain
研究概览
简要总结
The anaesthetic management of patients undergoing total knee replacement is still not standardised. Epidural analgesia is common, but is associated with bilateral lower limb motor block and limited mobilisation. Spinal anaesthesia with intrathecal morphine provides good pain relief, but only for 12 to 16 hours, and is often associated with nausea and vomiting. Combined single injection femoral / sciatic blocks give good pain relief, but for a variable length of time (between 12 and 24 hours).
In contrast, continuous femoral perineural infusion of local anaesthetic provides very good pain relief for several days. Pain relief is maintained by a constant infusion of local anaesthetic using an elastomeric ball. The investigators overriding aim is to develop a local anaesthetic regimen which offers complete pain relief for at least 48 hours, yet allows full mobilisation within 24 hours Given that ropivacaine may offer a more advantageous pharmacological profile (less lipid solubility) compared to levobupivacaine, the investigators feel it is pertinent to investigate the capacity of ropivacaine to prevent pain relief after surgery. Thus, the investigators aim in this study is to compare the median effective dose of levobupivacaine with the of ropivacaine for preventive pain relief after total knee replacement. Further, calculation of the equipotent median effective dose's of each local anaesthetic allied to objective measurement of quadriceps motor block using an electromyogram will allow us to determine the sensory - motor split of each local anaesthetic.
详细描述
Primary objective The primary aim of this study is to measure the molar of levobupivacaine and the molar median effective dose of ropivacaine when administered as a femoral perineural infusion to prevent pain 30 hours after total knee replacement Secondary objectives
To assess the:
Degree of postoperative pain, need for rescue analgesia,side effect profile of both groups, self-efficacy, expectancy, quality of life / health economics Type of study: Prospective single blind randomised controlled trial Planned number of subjects: 48 Study duration: 24 months Randomisation procedures Following informed consent, participants will be randomised into two groups. All preparations for study will be coded so that participants have an equal chance of receiving one of the two local anesthetics. Randomisation will be carried out by computer program, and codes kept in pharmacy in a sealed envelope.
Protocol for patient management Preoperative - Anaesthetic room Antibiotics: augmentin 1.2 grams Sedation with Target Controlled Infusion of propofol at plasma level of 0.5 micrograms per millilitre (μg.ml-1) Spinal anaesthesia with 3.2 ml hypobaric "plain" bupivacaine 0.5% and intrathecal morphine 0.1 mg All regional nerve blocks performed under ultrasound control Femoral block: 15 ml 0.3% levobupivacaine or ropivacaineFemoral perineural catheter inserted by Anaesthetist 5cm in a cranial direction Sciatic block: single injection 12 ml 0.5% levobupivacaine or ropivacaine Obturator block: single injection 6 ml 0.5% levobupivacaine or ropivacaine
Postoperative 8 hour anaesthetic observation
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients >18 years of age and non pregnant presenting for elective knee replacement
排除标准
- •Signs of cardiac failure (3rd heart sound, lung crepitations)
- •Type I and type II diabetes
- •Abnormal cardiac arrhythmias
- •Hypovolaemia
- •Presence of seizures,
- •Dementia,
- •Depression
- •Encephalopathy,
- •Terminal illness with a life expectancy < 3 months
- •Age < 18 years
- •Coagulopathy
研究组 & 干预措施
Levobupivacaine
Local anaesthetic bolus and infusion
干预措施: Ropivacaine (Drug)
Ropivacaine
Local anaesthetic bolus and infusion
干预措施: Levobupivacaine (Drug)
结局指标
主要结局
Pain
时间窗: 30 hours
Number achieving pain on movement of knee measured as 0 on a verbal pain rating scale at 30h after start of perineural infusion
次要结局
未报告次要终点