The Interest of the Xylocaine® and Ketamine on the Per and Postoperative Management of Acute and Chronic Postoperative Pain After Colectomy by Laparoscopy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Morphine consumption
研究概览
简要总结
Recent clinical studies in abdominal surgery have shown that the use of Xylocaine® parenterally intraoperative at plasma concentrations below the toxic threshold of 5 .mu.g / ml, had an analgesic effect and decreased postoperative morphine consumption.
This study aims to evaluate the activity of Xylocaine® and ketamine separately administered parenterally, in terms of postoperative morphine consumption and decrease incidences of postoperative chronic pain at 3 and 6 months after laparoscopic colectomy compared the placebo group.
The evaluation of the intensity of postoperative pain, hyperalgesia perished skin surface scarring) and pain perception threshold by Pain Matcher® confirm or not the predictive nature of these criteria in the occurrence of chronic pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Surgery: segmental or total colectomy performed by laparoscopy
- •Anesthesia state 1 and 3
排除标准
- •Patients classified Anesthesia state 4 or 5
- •Allergy or intolerance to any of the products used in the protocol
- •Creatinine clearance calculated by the Cockcroft formula below 50 ml / min
- •Hepatocellular insufficiency
- •Severe heart failure
- •Peptic ulcer
- •Chronic inflammatory bowel disease (IBD)
- •Previous history of epilepsy or seizures
- •Surgery emergency, palliative surgery, revision surgery
- •Chronic pain requiring regular intake of analgesics include opioids
- •Patients treated with lidocaine patch
- •Psychic Disorder
- •Additive Conduct vis-à-vis alcohol or mind-altering substances
- •Pregnant or breastfeeding women
研究组 & 干预措施
Xylocaine
intravenous administration
干预措施: Xylocaine (Drug)
Ketamine
intravenous administration
干预措施: Ketamine (Drug)
isotonic saline serum
isotonic saline serum intravenous administration
干预措施: isotonic saline serum intravenous administration (Drug)
结局指标
主要结局
Morphine consumption
时间窗: During the first 24 postoperative hours.
次要结局
- Morphine consumption(All 6 hours during the 48 postoperative hours.)
- Numeric rating scale score(All 2 hours during the first 24 postoperative hours and all 6 hours during the 48 postoperative hours.)
- Electric nociception threshold measured by PainMatcher(All 2 hours during the first 24 postoperative hours and all 6 hours during the 48 postoperative hours.)
- Questionnaire Douleur de Saint-Antoine (QDSA) ,(at 3 months, at 6 months)
- Hyperalgesia of peri-scar (in cm²) with a von Frey filament (pressure of 10 grams(At 2 days after postoperative)
- Time physiological function recovery(During the first 24 postoperative hours)
- Duration of hospital stay(At 5 days after postoperative)
- Questionnaire d'Evaluation des Douleurs Neuropathiques (QEDN),(at 3 months, at 6 months)