A Randomized Clinical Trial Estimating the Efficacy of Bolus Administration of Intravenous Lidocaine at the Time of Abdominal Hysterectomy to Decrease Postoperative Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Visual analog score during movement
研究概览
简要总结
The objective of the study to evaluate whether a bolus administration of intravenous lidocaine decreases postoperative pain and represents an opioid-minimizing strategy after abdominal hysterectomy compared with placebo.
详细描述
Total abdominal hysterectomy (TAH) is the most common gynecological operation worldwide. Some studies noticed about abused of opioids in postoperative care, led to a more adverse effect of opioids, slow recovery, prolong the length of hospitalized stay and consequently increase the unnecessary cost of treatment.
Guidelines have considered using preoperative analgesics for reducing post-operative opioids consumption, including lidocaine infusion. With its anti-inflammatory, anti-hyperalgesia and analgesic properties, intravenous perioperative lidocaine infusion (IVLI) has been used for optimal postoperative care in different surgeries and in various procedures involving hysterectomy.
Therefore, the aim of this study is to assess the efficacy of bolus administration of intravenous lidocaine at the time of abdominal hysterectomy to decrease postoperative pain and reducing morphine requirements, after TAH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participating patients, surgeons, anesthesiologists and medical investigators who will be involved in the data collection will be all blinded to the patient's group assignment until the collection of data for all cases will be complete.
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women ranging age between 35-60 years a who undergoing elective total abdominal hysterectomy
排除标准
- •Participants had known sensitivity to lidocaine
- •Participants had difficulty in intubation
- •Participants were on chronic pain medication or already on long-term opioids
- •Participants smokers
- •Participants with disabilities who were unable to communicate pain levels
- •refuse to consent
研究组 & 干预措施
lidocaine
A bolus intravenous dose of 1.5 mg/kg lidocaine 2% over 15 s just before the induction of general anesthesia.
干预措施: lidocaine (Drug)
Placebo
A bolus intravenous dose of a saline placebo over 15 s just before the induction of general anesthesia.
干预措施: Placebo (Drug)
结局指标
主要结局
Visual analog score during movement
时间窗: 30 minutes postoperative
movement-evoked pain measurements ranging from 0 to 10, where 0 no pain and 10 maximum pain
次要结局
- Visual analog score during rest(24 hours post operative)
- number of patients need Fentanyl consumption(24 hours post operative)
- number of days patients stay in hospital(4 weeks)
研究者
hany farouk
Principal Investigator
Aswan University Hospital