Effect of Perioperative Intravenous Infusion of Dexmedetomidine vs. Lidocaine on Postoperative Pain, Analgesic Consumption, Bowel Function and Recovery After Abdominal Gynaecological Surgery: a Randomised Double Blind Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- analgesic consumption 24 hours postop
研究概览
简要总结
Postoperative pain continues to be inadequately managed and is the most common reason for the delay in discharge and unplanned hospital admission after surgery. Opioids remain the mainstay for postoperative analgesia. However, there is a continuous search for adjuvant therapies to reduce the doses of opioids and their related adverse effects, and extend the use of non-opioid analgesia for acute pain after abdominal surgery, thereby improving patient recovery. Currently there are no clinical trials that investigate the effect of intravenous lidocaine vs dexmedetomidine on postoperative pain, analgesic consumption and bowel function of patients undergoing abdominal gynaecological surgery. Purpose of this prospective double blind randomised clinical trial is the investigation of the effect of perioperative intravenous infusion of lidocaine vs dexmedetomidine vs placebo (Normal Saline 0,9%) on analgesic parameters and functional recovery of patients undergoing abdominal gynaecological surgery.
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)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •30-70 years
- •abdominal gynaecological surgery
排除标准
- •patient's refusal
- •contraindication to the use of local anesthetics
- •body mass index >30 kg/m2
- •history of cardiovascular diseases/ arrhythmias/ conduction abnormalities
- •pregnant women
- •significant renal or hepatic impairment
- •insulin-dependent diabetes mellitus
- •central nervous system disease or psychiatric diseases
- •chronic use of opioids, steroids, clonidine (or other a2 agonist)
- •use of drugs acting on the central nervous system or analgesics during the previous 2 weeks
- •drug/alcohol abuse
- •inability to comprehend the following pain assessment scale
研究组 & 干预措施
Lidocaine
干预措施: Lidocaine Iv (Drug)
Dexmedetomidine
干预措施: Dexmedetomidine (Drug)
Normal Saline 0,9%
干预措施: Normal saline (Drug)
结局指标
主要结局
analgesic consumption 24 hours postop
时间窗: 24 hours postoperatively
morphine consumption from PCA
次要结局
- postoperative pain(48 hours postoperatively)
研究者
Staikou Chryssoula
Assistant Professor of Anaesthesiology
University of Athens