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临床试验/NCT05662566
NCT05662566已完成不适用

Cohort Study: Risk of Failed Epidural in Patients With and Without Chronic Pain and Opioid Use Undergoing Laparotomy

Eske Kvanner Aasvang1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年3月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
Epidural replacement

研究概览

简要总结

Patients with chronic pain syndrome (CPS) may develop central sensitization wich may lead to increased pain intensity and lower pain threshold sometimes to the extend of hyperalgesia and allodynia. Furthermore, patients with daily use of opioids may develop opioid tolerance, and to a lesser extent opioid induced hyperalgesia.

These factors may lead to a higher pain intensity in the perioperative setting resulting in the observed increased opioid dosage needed to treat the acute pain. Furthermore opioid titration may be difficult with higher levels of pain and a higher risk of opioid related adverse effects incl. respiratory depression and sedation.

The factors above advocate for utilizing opioid sparing analgesic techniques. In our department as in many others we use an multimodal opioid sparing approach for surgical procedures including epidural anesthesia (EA) as a standard part of the perioperative analgesia strategy after upper laparotomy, as a sufficient epidural anesthesia has shown to provide a stable and often better pain relief than systemic opioids in these patients.

Clinically, there is a suspicion that patients with CPS on fixed opioid treatment have a higher frequency of need for epidural optimization, despite the lack of an anatomical reason for this. One potential explanation could be an altered nociception, requesting another EA strategy than in non-opioid patients.

Purpose and hypothesis This study will explore the frequency of failed EA, defined as EA with insufficient analgesic effect to the extent were replacements of the epidural is needed within the first 5 postoperative days (PODs), testing the hypothesis that failed epidural occurs more frequent in patients with CPS on fixed opioid treatment than in non-opioid patients without CPS.

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

入选标准

  • Patients undergoing elective laparotomy with epidural anesthesia as a part of the postoperative pain treatment
  • For the intervention group - Patients with chronic pain disorder defined as pain for more than 3 months and a daily use of opioids regardless of dosage.
  • For the control group - No chronic pain disorder defined as no daily use of opioid or other medicine with strong analgetic effect. A daily use of Acetaminophen and NSAIDs were deemed acceptable.

排除标准

  • Patients with substance abuse
  • Suspected withdrawal due to opioid deficiency - noted in the medical chart

结局指标

主要结局

Epidural replacement

时间窗: 5 days postoperative

Number of patients with the need of a new insertion of the epidural catheter

次要结局

  • Length of stay at the - post anaesthetic care unit (PACU) / Ward / Hospital(Total time of hospital stay up to 52 weeks)
  • postoperative epidural optmisation(5 days postoperative)
  • Number of epidural replacements(5 days postoperative)

研究者

发起方
Eske Kvanner Aasvang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Eske Kvanner Aasvang

Professor, MD, DMSci

Rigshospitalet, Denmark

研究点 (1)

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