跳至主要内容
临床试验/NCT06499792
NCT06499792招募中不适用

Effectiveness of the Transversus Abdominis Plane Block (TAP-Block) Associated With Opioid Spinal Anesthesia on Analgesia After Cephalic Duodenopancreatectomy

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2024年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
160
试验地点
1
主要终点
Consumption of Morphine in the first 24 hours postoperatively.

研究概览

简要总结

Duodenopancreatectomy is a major, risky surgery that causes significant post-operative pain. Optimizing perioperative analgesia remains a challenge, and requires multimodal management, notably involving locoregional analgesic techniques.

The thoracic epidural helps reduce perioperative pain, as well as certain postoperative complications. However, epidural analgesia is not without effects, and the data remains quite heterogeneous depending on the studies regarding its benefits and risks: more frequent hypotension, significant technical failures, length of hospitalization depending on the series, marginal benefit clinically of little relevance... And the existence of contraindications to the epidural such as the performance of vascular resections requiring curative intraoperative anticoagulation also limit its daily use.

The search for alternatives to the epidural in this context has seen the emergence of the use of intrathecal injection of Morphine and the performance of TAP Block perioperatively for duodenopancreatectomies. Morphine spinal anesthesia is an analgesic technique that is simpler and just as effective as the thoracic epidural. The TAP Block has also proven its effectiveness in major colorectal surgeries.

The literature on the subject remains poor and very few studies have focused on alternatives to thoracic epidurals. If the superiority of TAP Block and spinal anesthesia have been evaluated in isolation, no study has yet compared the effectiveness of the combination of TAP Block-Spinal anesthesia compared to that of TAP Block alone in the management of post pain. duodenopancreatectomy.

At the Strasbourg University Hospital, the Anesthesia team in hepatic and pancreatic surgery made a change in practice in June 2023: from a TAP Block, the team performs a TAP-Block combined with a unique Morphinic spinal anesthesia preoperatively for cephalic duodenopancreatectomy (CDP). The objective of the study is to evaluate the effectiveness and safety of this change in practice.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

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

  • •Major subject (≥18 years old)
  • •Planned cephalic or total duodeno-pancreatectomy surgery, associated or not with additional vascular procedures or liver resections by laparotomy, at the Strasbourg University Hospital for the period from June 1, 2022 to May 31,
  • •Subject who has not expressed opposition to the reuse of their data for scientific research purposes.

排除标准

  • •Subject having expressed opposition to participating in the study
  • •Admission to intensive care following the operation
  • •Drug addiction withdrawn or not
  • •Surgery shortened by surgical decision

结局指标

主要结局

Consumption of Morphine in the first 24 hours postoperatively.

时间窗: Up to 1 year

Quantitative variables are described using the usual position and dispersion statistics, namely mean, median, minimum, maximum, standard deviation and quantile. The qualitative variables are described with the numbers and proportions of each modality. The Chi2 test will be used to study the crossover between several qualitative variables. The risk of the first kind is set at 5% for all analyses.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验