To analyse the effect of topicalization of Glissonian capsule with 2% Lignocaine on anaesthetic drug doses for Monitored anaesthesia care in Percutaneous radiofrequency ablation of Liver.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- To achieve a visual analogue pain score of 3 during the procedure.
研究概览
简要总结
Percutaneous radiofrequency ablation (PRFA) of solid tumors is a minimally invasive procedure to treat primary and/or metastatic solid tumors via thermal tissue destruction as a result of targeted thermal energy deposition and coagulative necrosis. Glisson’s capsule, the fibrous covering of the liver, is innervated by branches of the lower intercostal nerves which carries sensory pathway for pain. The RFA of a subcapsular tumor causes generation of heat and gases due to burning of tumor tissue. This in turn stimulates the sensory nerve endings at the Glisson’s capsule causing severe pain. This also make the ablation difficult as patient moves due to pain and may thus displace the ablation needle.
Most common method of sedation and analgesia for such procedures include: intravenous opioids, dexmedetomidine infusion, inj. ketamine and propofol. Mixture of these drugs in different doses helps the radiologist to complete the procedure with calm patient when the lesion is in liver parenchyma. For subcapsular region, the situation is different. To combat severe pain due to liver capsule irritation, high doses of these drugs are given which in turn also causes respiratory depression and obstructed airway further complicating the situation. Most commonly used drugs for such scenario are propofol and ketamine.
In view of these issues we propose a hypothesis that topicalization of Glissonian capsule with 2% lignocaine will provide adequate analgesia and reduces the dosage of anaesthetic drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •1.ASA Grade(I-III) 2.All patients with Subcapsular Liver lesion posted for RFA/microwave ablation.
排除标准
- •1.Patients with history of M.I, Arrythmia or any other cardiac morbidity.
- •2.Difficult airway 3.Deranged liver function test and coagulation profile 4.Chronic alcoholic 5.History of any cognitive or psychiatric illness 6.Patients on medication for chronic pain 7.Allergy to Lignocaine 8.Patient on ventilator, poor GCS.
结局指标
主要结局
To achieve a visual analogue pain score of 3 during the procedure.
时间窗: 0 min Baseline preprocedure | 2 min after start of procedure | 6 min after start of procedure | 8 min after start of procedure | 10 min after start of procedure
次要结局
- To compare visual analogue score in post procedure period(0 hour immediate post procedure)
- Heart Rate(0 min Baseline preprocedure)
- Mean arterial pressure(0 min Baseline preprocedure)
- Respiratory rate(0 min Baseline preprocedure)
- To compare the Observer assessment of alertness score(0 min Baseline preprocedure)
- Arterial oxygen saturation(0 min Baseline preprocedure)
- To compare the patient, anaesthetist and Interventional radiologist satisfaction score.(Post procedure)
