Continuous vs. Bolus Administration of NSAIDs After Laparoscopic Surgery for Multimodal Analgesia: Pilot Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Opioid consumption
研究概览
简要总结
Currently the prevalent approach to perioperative management of patients is ERAS (Enhanced Recovery After Surgery) concept. This approach includes numerous aspects, among which the perioperative use of multimodal analgesia takes one of the leading places. Within the ERAS guidelines all sorts of minimization of opioid analgesics use in schemes of postoperative analgesia are appreciated. Thus, new pharmacological approaches are being actively developed currently in order to achieve adequate analgesia and to minimize the use of this group of drugs.
One of the most perspective trends within the multimodal analgesia concept is continuous infusion of non-steroidal anti-inflammatory drugs (NSAID). Up to date there are papers that both confirm the effectiveness of this method for maintaining adequate postoperative analgesia and show its limitations and deny the advantages of the continuous use of NSAID.
Up to this time the main attention of the medical community was paid for such drugs as paracetamol and ketoprofen. Nevertheless, one of the most common and safe NSAID is ibuprofen. In spite of this, there are no studies that explore the effectiveness of the continuous infusion of this drug. Thus, the lack of even low-quality evidence led to setting up a study of effectiveness and safety of continuous infusion of ibuprofen in comparison to its bolus injection.
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, 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
- 否
入选标准
- •Age > 18 years old
- •Elective laparoscopic surgery
- •General anesthesia
- •Signed informed consent from the patient to participate in the study
- •RASS scale from -2 to +1 on admission to a surgical department or ICU
排除标准
- •History of ibuprofen allergy
- •Active erosive or ulcerative lesions of the gastrointestinal tract
- •Chronic use of opioid analgesics or NSAIDs prior to enrollment
- •Chronic kidney disease ≥ 3b stage according to the KDIGO classification
- •Liver dysfunction (three times exceeding the upper reference limit of ALT or AST)
- •A history of bronchial asthma
- •A history of hereditary coagulopathies
- •A history of use of anticoagulants
研究组 & 干预措施
NSAID bolus injection
干预措施: Ibuprofen bolus injection (Drug)
NSAID continuous infusion
干预措施: Ibuprofen continuous infusion (Drug)
结局指标
主要结局
Opioid consumption
时间窗: up to 28 days
Evaluation of the overall consumption of opioid analgesics after surgery during the whole postoperative period
次要结局
- Pain intensity assessment(From admission to ICU until 48 hours postoperatively)