ACTRN12622000538741已完成2 期
A pilot randomised controlled trial of lidocaine for post-traumatic and post-surgical neuropathic pain: Does dose or patient profile modify the outcome?
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •The inclusion criteria are
- •- Adults with a documented diagnosis of peripheral neuropathic pain (sensory changes affecting the region of the primary pain as well as qualities identified to be indicative of neuropathic pain in the current short form of the McGill Pain Questionnaire (SF-MPQ-2) and the painDETECT questionnaire.
- •- Pain for at least 6 weeks duration with moderate to high intensity (average pain at least 5 and worst pain at least 7 on the numerical rating scale) and localised to one side of the body.
- •- Pain not responsive to other forms of treatment or treatment side effects with oral agents
- •- Absence of pain affecting the opposite quadrant to the primary site of neuropathic pain. This criterion excludes whole-body pain presentations that are likely to have quite a different combination of dominant pain mechanisms and enables the opposite quadrant to be used as a pain-free remote site for quantitative sensory testing.
排除标准
- •The exclusion criteria are
- •- Inability to understand and respond to instructions and questions in English, or inability to write in English.
- •- A previous history of a intravenous lidocaine infusion while not under general anaesthetisia, currently receiving lidocaine or its oral analogues (mexiletine or flecainide). Previous intraoperative lidocaine infusion will be noted, but will not be an exclusion criterion.
- •- Contraindications or precautions for intravenous lidocaine infusion that are included in standard clinical screening for contraindications and precautions for lidocaine administration, as noted on the TGA Product and Consumer Medicine Information Licence for lidocaine:
- •i) Arrhythmia such as atrial fibrillation, conduction blocks, pacemaker/automatic implantable cardioverter defibrillator, or use of anti-arrhythmic medication. A resting heart rate of under 50 BPM and over 100 BPM.
- •ii) Moderate to severe cardiac failure, uncontrolled hyper (>170/100) or hypotension (<100/60), severe hepatic, renal, thyroid, diabetes, infections, or haematological conditions. As clinically indicated, the study team will order pathology tests to identify/exclude these conditions.
- •iii) Seizure disorders that would present a safety risk during infusion or quantitative sensory testing.
- •iv) Cognitive limitations or psychiatric disorders where the condition is unstable or limiting ability to attend to and to consistently report body perceptions or complete questionnaires (may include schizophrenia, somatization, or acute anxiety), which would contribute increased risk with lidocaine or application of quantitative sensory testing.
- •v) Pregnancy or breastfeeding.
- •vi) Allergies, interaction with current medications or abnormal lidocaine sensitivity.
- •- Health conditions that contraindicate quantitative sensory testing due to increased tissue vulnerability with pressure or thermal stimuli.
- •- Concomitant neurological conditions that limit peripheral nervous system function in the region of the primary post-trauma pain, or neurological conditions that affect the central nervous system (as moderate traumatic brain injury).
- •- Body weight >100 kg, as higher weight would require greater than the standard clinical practice maximum dosage of 500mg of lidocaine, to deliver 5mg/kg.
- •- An electrocardiograph recording will be made to examine for any alterations in trace that would contraindicate lidocaine infusion.
- •i) This can include a previous ECG within the last 6 months
- •ii) It can be ordered at the time of screening examination for review later (undertaken at a local facility or at the RBWH).
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