Intra-epidermal Nerve Fibre Density and Its Relationship to Post-caesarean Section Pain
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Chronic Pain
研究概览
简要总结
Chronic pain is a significant burden to the individual and society with post-surgical pain identified as a research priority for the speciality of anaesthesia.
The objectives are to explore the relationship between IENFD and pain after caesarean section and to explore the characteristics of post-caesarean section pain.
The hypothesis is that reduced pre-operative IENFD at the surgical site will correlate with risk of developing CPSP.
详细描述
Based on the existing evidence, chronic pain after caesarean section appears to have an incidence between 12-18%; with the current Scottish caesarean section rate, this equates to approximately 3000 young, active women each year. Their lives may be affected by pain leading to increased analgesic use, a restriction of daily activities, decreased quality of life, and increased utilisation of healthcare services. The National Institute of Academic Anaesthesia (NIAA) has undertaken a priority setting exercise with 1700 patients and clinicians and declared the prevention of chronic post-surgical pain as one of its top 10 research priorities for the speciality of Anaesthesia.
IENFD is calculated by counting the number of nerve fibres crossing the basement membrane through direct visualisation of a skin biopsy that has undergone immunohistochemical staining. Skin biopsy is minimally invasive and allows visualisation of small fibre nociceptors that are not suitable for identification or study through nerve conduction studies.
There is emerging evidence from clinical studies that chemotherapy induced peripheral neuropathy (CIPN) patients have altered sensory innervation compared to healthy controls. In both colorectal cancer and multiple myeloma, pre-oncological treatment reductions in IENFD were associated with changes in physical testing, confirming a subclinical sensory deficit. The degree of loss of IENFD correlates with development of mechanical hyperalgesia and patients with greater sensory loss at baseline developed more symptoms during and after chemotherapy. To date there have been no studies that have examined the relationship between a patient's pre-operative IENFD and the development of chronic post-surgical pain.
This single cohort observational study shall recruit women undergoing elective caesarean section within the Simpson's Centre for Reproductive Health (SCRH). All women shall be sent a patient information sheet with a covering letter one week prior to the date of the surgery.
There shall be five discrete data collection points:
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women undergoing an elective caesarean section
- •Aged 18-65 years
排除标准
- •Women undergoing urgent caesarean section
- •Women with little or no English language skills - the questionnaires used are only validated for use in the English language.
- •Women with cognitive impairment or mental health disorder that inhibits their ability to provide consent and/or participate in follow-up
结局指标
主要结局
Chronic Pain
时间窗: 6 months
Does the patient have pain at the operation site. A binary measure (yes or no).
次要结局
- Brief Pain Inventory Score(6 months)
- Short Leeds Assessment of Neuropathic Signs and Symptoms(6 months)
研究者
Oliver Daly
Consultant Anaesthetist, NRS Career Research Fellow
Royal Infirmary of Edinburgh