Analgesic Effect of Bilateral Quadratus Lumborum Block in the End of Colorectal Laparosopic Surgery: a Prospective Randomized Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Morphine Consumption in milligramme
研究概览
简要总结
The primary purpose of COLOQUAL study is to demonstrate the superiority of analgesic effect of a bilateral quadratus lumborum block (QLB), performed at the end of laparoscopic colorectal surgery, compared to standard of care.
The investigators hypothesized that a bilateral quadratus lumborum block performed at the end of laparoscopic colorectal surgery would reduce the incidence of post operative pain, time spent in recovery room, improve patient's satisfaction, and reduce hospitalisation time
详细描述
Visits:
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The patient will arrive in the department the day before the surgical intervention (Day-1). During this preoperative visit (Day-1), the investigator
-
will preselect potentially eligible patients
-
will offer to participate to this study
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will give the notice form to the patients
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will present the research: objectives, benefits and constraints for the patients
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The intervention day (Day 0):
The investigator will collect the signed consent form after having ascertained the understanding of the notice form by the patient and checking the inclusion and non-inclusion criteria.
The randomization will be done via the eCRF module (allocation group and number) and the preoperative data registration in the eCRF.
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
- Single (Participant)
盲法说明
During the assess period, the participant and the research staff involved in the data collection will be blinded to the randomization group
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
- •Age > 18 years old
- •Patients operated of a scheduled laparoscopic colorectal surgery
- •Patients having given consent in the mannen described in Article L1122-1-1 of the Public Health Code
- •Patients affiliated with asocial security regimen or beneficiary of such a regimen
排除标准
- •Renal insufficiency (ie glomerular filtration output < 35 ml/min)
- •Patients with chronic inflammatory bowel disease
- •Body mass index > 35 kg/m2
- •Chronic pain with opiates
- •Patients with cognitive troubles
- •Coagulation disorders (platelets count < 80G/L, PT< 50%, V factor < 50%)
- •Pregnancy
- •Breastfeeding
- •Local anesthesics (amide class) allergy
- •Laparotomy conversion
结局指标
主要结局
Morphine Consumption in milligramme
时间窗: 8 AM (ante meridiem) the day after surgery
Once the patient is transferred in post operative surgical service, assessment of the primary outcome will be done by the nurse in charge of the patient
次要结局
- NRS (Numeric rating scale)(At the entrance of recovery room, at day 1 and Day 2 after surgery)
- Post Operative recovery: QUO-R4O questionnaire(At Day 1 and day 15 after surgery)
- Time spent in recovery room (in minutes)(At the output of recovery room ie until 6 hours after intervention)