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临床试验/NCT03881124
NCT03881124已完成不适用

Pain Trajectories in Severe Persistent Inguinal Post-herniorrhaphy Pain

University of Copenhagen0 个研究点目标入组 95 人开始时间: 2014年8月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
95
主要终点
Group IV pain trajectories

研究概览

简要总结

Severe persistent postsurgical pain (PPP) remains a major healthcare challenge. In the third most common surgical procedure in the UK, inguinal herniorrhaphy, including 85,000 surgeries in 2015, an estimated 1,500 to 3,000 patients will annually develop severe PPP. While the trajectory of PPP is generally considered a continuation of the acute post-surgery pain, recent data suggest the condition may develop with a delayed onset. The present study evaluated pain-trajectories in a consecutive cohort referred to a tertiary PPP-center. Explanatory variables based on individual psychometric, sensory and surgical profiles were analysed.

详细描述

Severe persistent post-surgical pain (PPP) is a prevalent medical problem leading to impairment of physical and psycho-social functions in a large number of individuals.Severe PPP may significantly influence 4-8% of the surgical population, depending primarily on the surgical procedure and technique, but also patient-related pre-surgical factors.Updated criteria for PPP have recently been suggested. Inguinal herniorrhaphy qualifies for PPP-research due to a high surgical volume. Paradoxically, while the surgery is considered a minor procedure with limited tissue damage it is carried out in a territory with abundant nerve and vascular supply, and, complex musculoskeletal functions essential for locomotor actions. Persistent pain after inguinal herniorrhaphy may develop after a seemingly successful surgical procedure, and, is seen in a severe form in 2-4% of the patients associated with significant deterioration of the health-related quality of life.

The transition process from acute to persistent pain may be more complex than previously assumed, making the study of temporal pain trajectories interesting. Based on clinical experience from a nationwide research center in PPP following inguinal herniorrhaphy, the authors decided first, to perform a prospective exploratory cohort study examining graphical pain charts by planimetrics, attempting to construct a valid statistical sub-classification of the trajectories. Secondly, the relationship between the sub-classification of the trajectories, and, potential explanatory variables, based on individual profiles of pain, psychometrics, quantitative sensory testing, and surgical procedures, were analysed, using principal component analysis and logistic regression models.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

入选标准

  • Patients with severe persistent pain (>6 mo) after groin hernia repair referred to our center for PPP

排除标准

  • Unable to cooperate with the sensory examinations

结局指标

主要结局

Group IV pain trajectories

时间窗: 2014-2016

Trajectories are examined by area-under-curve using normalized pain intensities (numeric rating scale values 0-10 \[y-axis\]) and normalized time points (years \[x-axis\]) in patients where pre-surgical high-intensity pain continued unchanged post-surgically.

Group II pain trajectories

时间窗: 2014-2016

Trajectories are examined by area-under-curve using normalized pain intensities (numeric rating scale values 0-10 \[y-axis\]) and normalized time points (years \[x-axis\]) in patients where the acute post-surgical pain decreased significantly to low-intensity levels, but pain recurred developing into high-intensity PPP

Group III pain trajectories

时间窗: 2014-2016

Trajectories are examined by area-under-curve using normalized pain intensities (numeric rating scale values 0-10 \[y-axis\]) and normalized time points (years \[x-axis\]) in patients where repeat-surgery precipitated high-intensity PPP

Group I pain trajectories

时间窗: 2014-2016

Trajectories are examined by area-under-curve using normalized pain intensities (numeric rating scale values 0-10 \[y-axis\]) and normalized time points (years \[x-axis\]) in patients with sustained severe where the acute post-surgical pain continued into persistent post-surgical pain (PPP) with unchanged high-intensity pain

次要结局

  • Activity of Daily Living (ADL) score(2014-2016)
  • Assessments of Anxiety and Depression(2014-2016)
  • Assessment of Pain Catastrophizing(2014-2016)
  • S-LANSS(2014-2016)
  • Pain intensity(2014-2016)
  • Quantitative sensory testing (QST)(2014-2016)
  • painDETECT(2014-2016)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

mads u werner

Principal Investigator

University of Copenhagen

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