Opioid-free Anesthesia as an Alternative to General Anesthesia in Patients Undergoing Laparoscopic Peripheral Pancreatic Resection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Opioid consumption
研究概览
简要总结
Opioid-free anesthesia is not associated with greater pain than opioid anesthesia and is associated with reduced postoperative pain.
详细描述
In our study, the investigators would like to compare the measurement of total oxycodone consumption in the postoperative period in both groups and whether the use of opioid-free anesthesia would reduce opioid consumption by 30%. The secondary objective will be to assess pain in both groups during the first 48 postoperative hours in patients undergoing pancreatic surgery. Patients would be randomly assigned to anesthesia with and without opioids at 1, 2, 6, 12, 24, and 48 hours after surgery. Other secondary objectives include assessing the incidence of postoperative nausea and vomiting (PONV), adverse drug reactions, particularly cardiac arrhythmias, and the impact on persistent postoperative pain. On day 7 after surgery, each patient will receive the QOR-15 questionnaire to assess quality of life and the PQA-10 questionnaire.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient consent to participate in the study
- •Qualified for laparoscopic peripheral pancreatic resection
- •Age 18-80 years
- •ASA II and III
排除标准
- •Patient refusal to participate in the study
- •Inability to operate a PCA pump
- •Lack of understanding of the NRS scale
- •Hypersensitivity to anesthetics
- •First- or second-degree heart block.
研究组 & 干预措施
Balanced anesthesia with opioids
Patients who will have pancreatic operation under balanced anesthesia including opioids
干预措施: Balanced anesthesia with opioids (Drug)
Opioid Free Anesthesia (OFA)
Patients who willl have pancreatic operation under Opioid Free anesthesia
干预措施: Opioid Free Anesthesia (OFA) (Other)
结局指标
主要结局
Opioid consumption
时间窗: up to 48 hours after surgery
measurement of total oxycodone consumption in the postoperative period
次要结局
- Pain assessment(at 1, 2, 6, 12, 24, and 48 hours after surgery)
- PONV(up to 48 h after surgery)
- Quality Of Recovery(on the 7th day after surgery)
研究者
Tomasz Skladzien
older asistent
Jagiellonian University