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临床试验/NCT04052867
NCT04052867Unknown不适用

Intravenous Lignocaine Infusion as a Multimodal Analgesic Approach in Laparoscopic Donor Nephrectomy

University of Malaya1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年9月17日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Postoperative morphine requirement

研究概览

简要总结

Background:

Administration of morphine as boluses or via a patient controlled analgesic device (PCA) has been the standard practice for donors after nephrectomy.

However, administration of morphine is far from being ideal analgesic as it does not provide optimal dynamic pain relief after major surgery, consistently demonstrate little effect on surgical stress response and organ dysfunction with high incidences of postoperative nausea/vomiting, respiratory depression and sedation. Several studies demonstrated perioperative intravenous lignocaine infusion can improve post-operative pain scores and morphine consumption in abdominal surgery.

The aim of this study is to identify the effectiveness of intra-operative lignocaine infusion in lowering postoperative pain and reduce postoperative morphine consumption in patients who undergo laparoscopic donor nephrectomy.

详细描述

Hypothesis:

Patients who receive intravenous lignocaine infusion as a multimodal analgesic technique will require less morphine postoperatively with lower pain scores on the visual analogue scale (VAS).

Methodology The main clinical study is a randomized double blinded control trial that will start after ethics approval from UMREC and registration at Clinical Trial Registry. All adults undergoing elective laparoscopic donor nephrectomy will be recruited in this double-blinded randomised controlled trial. After obtaining their informed consent, patients will be shown the visual analogue score (VAS) as the post-operative pain assessment and their baseline pain scores obtained. Instructions are also given for patient controlled analgesic (PCA) device using morphine for post-operative pain control.

Randomisation and blinding:

There will be two groups - lignocaine and control. Randomization will be based on a computer generated random number and sealed in opaque envelopes. On the day of surgery, one of the investigators who must not be involved in the care of the case, opens the envelope to follow the allocated group number and prepare either lignocaine or normal saline solutions. Both syringes are labelled with the assigned number only and handed to the attending anaesthesiologist in charge of the surgery. The patient as well as the attending anaesthetic team is blinded to the allocated group. Similarly, post-operative observers who collect the required data will be blinded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • elective laparoscopic donor nephrectomy

排除标准

  • refuse consent
  • allergic to local anaesthetics or opioids,
  • on long term analgesics for chronic pain,
  • have impaired liver function
  • has history of arrhythmias

研究组 & 干预措施

Lignocaine group

Experimental

20 patients undergoing elective laparoscopic donor nephrectomy will be given lignocaine infusion as part of the perioperative pain management.

干预措施: Lignocaine (Drug)

Control group

Active Comparator

20 patients undergoing elective laparoscopic donor nephrectomy will be receiving an equivalent volume of normal saline.

干预措施: Normal saline (Drug)

结局指标

主要结局

Postoperative morphine requirement

时间窗: 24 hours postoperatively

Morphine usage post-operatively

次要结局

  • Level of systemic lignocaine(before lignocaine infusion, after lignocaine infusion just before nephrectomy, half hour after nephrectomy, within 24 post operatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Loh Pui San

Consultant Anaesthesiologist

University of Malaya

研究点 (1)

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