Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy: A Randomized Controlled Double-Blind Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Opioid consumption
研究概览
简要总结
The goal of this clinical trial is to determine whether continuous nefopam administration, as part of a multimodal analgesia strategy, reduces opioid consumption and improves patient satisfaction after pancreatoduodenectomy.
The main questions are:
Does nefopam administration reduce opioid consumption after pancreatoduodenectomy?
Does nefopam administration reduce postoperative pain levels after pancreatoduodenectomy?
Researchers will compare two other analgesic strategies, namely continuous lidocaine infusion and epidural analgesia, to assess whether they lead to better outcomes.
Participants will complete the QoR-15 questionnaire and report their pain levels at predefined time points before and after surgery.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective pancreatoduodenectomy surgery
- •Agreed to participate in the study
排除标准
- •Refusal to participate
- •Emergency surgery
- •Patients with neurological disorders or other muscular or psychiatric disorders that impede communication
- •Known allergic reactions to the used medication
- •Known hyperalgesia
- •Chronic opioid consumption
- •Patients that require reintervention in the first 48h postoperatively
- •Patients with pancreaticogastrostomy
研究组 & 干预措施
Peridural
Patients will receive standard multimodal analgesic medications plus epidural analgesia during the postoperative period.
干预措施: Peridural (Drug)
Peridural
Patients will receive standard multimodal analgesic medications plus epidural analgesia during the postoperative period.
干预措施: Multimodal IV analgesia (Drug)
Nefopam
Patients will receive standard multimodal analgesic medications plus continuous nefopam infusion from the intraoperative through the postoperative period.
干预措施: Nefopam 120mg/day infusion (Drug)
Nefopam
Patients will receive standard multimodal analgesic medications plus continuous nefopam infusion from the intraoperative through the postoperative period.
干预措施: Multimodal IV analgesia (Drug)
Lidocaine
Patients will receive standard multimodal analgesic medications plus continuous lidocaine infusion from the intraoperative through the postoperative period.
干预措施: Lidocaine Infusion (Drug)
Lidocaine
Patients will receive standard multimodal analgesic medications plus continuous lidocaine infusion from the intraoperative through the postoperative period.
干预措施: Multimodal IV analgesia (Drug)
结局指标
主要结局
Opioid consumption
时间窗: From enrollment to 48 hours after the surgery
Perioperative opioid consumption, expressed in morphine milligram equivalents, during the intraoperative period and within the first 6, 18, 24, and 48 hours postoperatively.
Pain levels after surgery
时间窗: From enrollment to 48 hours after the surgery
Numeric Rating Scale (NRS) pain scores at rest and during straining (coughing), assessed at 30 minutes, 6 hours, 18 hours, 24 hours, and 48 hours postoperatively.
次要结局
- Quality of Recovery (QoR-15)(From enrollment to 48 hours after the surgery)
- Adverse events(From enrollment to 48 hours postoperative)
研究者
Andrei Mitre
MD
Iuliu Hatieganu University of Medicine and Pharmacy