Characterising the Phenotype for Persistent Postoperative Pain Following Repair of the Thoraco-abdominal Aorta
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Characterise the analgesia requirements as a change measure following Thoracoabdominal Aortic Surgery
研究概览
简要总结
This is an observational clinical study aiming to further the wider understanding of patients who develop persistent pain after Thoracoabdominal Aorta surgery, a surgical cohort who are disproportionately affected. This will be undertaken through a prospective biopsychosocial characterisation of the phenotype of patients undergoing this operation.
Increasing numbers of patients are undergoing surgery on the chest for treatment of heart or lung cancer disease. Over the last twenty years, the medical community has become increasingly aware of the long-term effect of this surgery in producing persistent pain, approximately half of all survivors are still in pain around their surgical incision at three months postoperatively and beyond. There is currently no accepted method for preventing this phenomenon.
The nervous system mechanisms for the development of persistent pain after surgery are unclear. Some studies suggest it may involve the patient's ability to dampen down pain signals travelling from the incision site to the brain.
Humans have an in-built system that produces opiates as well as other pain-relieving molecules in response to injury, e.g. surgery. However, this response varies hugely from person to person and may even be impacted by the psychological state of the individual at the time of surgery. Some of these pain modulating mechanisms can be measured before and after surgery in patients using sensory testing, a robust and established objective method to assess patients'.
Identifying patients who are most at risk of a persistent pain state will allow both academics and clinicians to investigate and better target appropriate treatments.
Undertaking these longitudinal observational assessments will facilitate an improved mechanistic insight of the transition from acute to pathological pain, with the ultimate goal of improving outcomes for patients'.
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
- 否
入选标准
- •Adults (over 18 years of age) undergoing elective repair of the thoraco-abdominal aorta. Able to adequately understand and respond to verbal instructions
排除标准
- •Unwilling or unable to give consent, Age <18 years
研究组 & 干预措施
Develop Persistent Postsurgical Pain
Pain present 3 months post-op related to the surgical operation
Absence of Persistent Postsurgical Pain
Resolution of post-operative pain within the first three months of the operation
结局指标
主要结局
Characterise the analgesia requirements as a change measure following Thoracoabdominal Aortic Surgery
时间窗: 3 years
Analgesic requirements as measured by oral morphine equivalents (Pre-Op, Throughout the peri-op period and till 2 years post-op)
Characterise the presence of neuropathic sensory phenotype of patients undergoing Thoracoabdominal Aortic Surgery pre-op, post-op and > 3 months post-op.
时间窗: 3 years
Neuropathic Pain as defined by Douleur Neuropathique 4 (DN4) (Pre-Op, \> 3 months Post-op and till 2 years post-op)
Characterise the Pain Intensity as a change measure following Thoracoabdominal Aortic Surgery
时间窗: 3 years
Pain Intensity as measured by Visual Analogue Score (Pre-Op, Pre discharge, after three months post-op)
Characterise the change in biochemical phenotype pre-op and in the early post-op period following Thoracoabdominal Aortic Surgery and define significant differences between those with and without persistent post surgical pain
时间窗: 3 Years
Multi regression analysis of CSF composition.
Identify Predictors of Persistent Postsurgical Pain following Thoracoabdominal Aorta surgery
时间窗: 3 years
Determine if a composite biomarker or non response to conditioned pain modulation is a biomarker for development of persistent post-surgical pain and whether these are associated with biochemical differences through a bioinformatic data analysis approach.
Characterise the sensory phenotype of Persistent Postsurgical Pain following Thoracoabdominal Aortic Surgery with Quantitative Sensory Testing as a change measure.
时间窗: 3 Years
Quantitative Sensory Tests (Pre-op, Early Post-operative Period, \> 3 months Post-op)
Characterise the change in biochemical phenotype pre-op and in the early post-op period following Thoracoabdominal Aortic Surgery and define significant differences between those with and without persistent post surgical pain
时间窗: 1 Week
Multi regression analysis of blood composition.
次要结局
- Determine the influence of baseline psychological and social profiles on postoperative pain outcomes.(3 years)
- Describe the impact of Persistent Post Surgical Pain on Quality of Life(3 years)