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临床试验/NCT03938168
NCT03938168已完成不适用

PAIN PAD Histological and Molecular Mechanisms of Pain in Patient With Chronic Pain From Adhesions

Radboud University Medical Center3 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2019年4月9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
61
试验地点
3
主要终点
TRPV-1

研究概览

简要总结

11-20% of patients undergoing abdominal surgery develop chronic abdominal pain. Adhesions are a common cause of chronic pain following surgery. Adhesions develop after up to 90% of laparotomies and 70% of laparoscopic surgeries. Obviously, not all adhesions cause pain. It is still poorly understood why adhesions cause pain in some patients, while other patients with adhesions experience no pain.

In this study we explore possible mechanism through which adhesions might cause pain. For this purpose we will assess expression of molecular mediators (such as TRPV-1, SP, and the neurokinin receptor), histological characteristics, and fecal microbioma that might be associated with pain.Expression of these factor will be compared to sample from 30 patients with chronic pain attributed to adhesions, and 30 patients undergoing a reoperation with adhsiolysis for reasons unrelated to pain.

详细描述

Introduction and rationale:

11-20% of patients undergoing abdominal surgery develop chronic abdominal pain. Adhesions are the most common cause of chronic abdominal complaints after surgery. Chronic pain from adhesions has devastating consequences for quality of life, and one in three patients with pain from adhesions is opioid dependent.

Adhesions develop after up to 90% of laparotomies and 70% of laparoscopic surgeries. Obviously, not all adhesions cause pain. It is still poorly understood why adhesions cause pain in some patients, while other patients with adhesions experience no pain.

In a recent study we demonstrated that in selected patients adhesion-related pain can effectively be treated by operation with adhesiolysis and application of an adhesion barrier. However, almost 50% part of patients with adhesion-related pain are not considered a candidate for surgical treatment, for various reasons.

Exploring the mechanisms that contribute to development of pain in patients with adhesions could provide novel targets for medical therapies. These could greatly benefit many patients suffering from adhesion- related pain. Two factors that might explain why some patients with adhesions develop chronic pain are activation of molecular mechanisms involved in chronic pain and stimulation of nerve fibers present in adhesions. Specifically type C nerve fibres are associated with development of neuropathic pain. Further we will also explore differences in microbioma, which has recently been demonstrated to have an important role in a variety of abdominal conditions.

研究设计

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

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

TRPV-1

时间窗: during surgery

mRNA expression levels of TRPV1 by quantitative polymerase chain reaction (qPCR)

次要结局

  • TRPV-1 protein(during surgery)
  • NK-1(during surgery)
  • SP(during surgery)
  • Nerve fibers(during surgery)
  • Microbioma(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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