Affecting Factors for the Incidence of Chronic Pain After Mastectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Self-leeds assessment of neuropathic symptoms and sign findings in 3rd months.
研究概览
简要总结
Chronic post-mastectomy pain (CPMP) is a significant issue affecting many women after mastectomy. Factors like age, treatment type, and pre-surgery pain can increase the risk of developing this condition. By evaluating these factors, CPMP can be prevented more successfully and treatment strategies can be developed. This study aims to investigate the factors contributing to CPMP and contribute to the existing literature on this important topic.
详细描述
Chronic post-mastectomy pain (CPMP) is a common condition and is a significant clinical problem with a prevalence reported in the literature of up to 50%. Approximately 10% of patients experience severe pain, which has a significant impact on their quality of life. Since mastectomy is a frequently performed procedure, this syndrome affects a large number of women. Therefore, it is important to better understand the factors associated with the development of persistent pain.
Several theories have been proposed regarding the development of CPMP, including increased peripheral nociceptor sensitivity (primary hyperalgesia) at the site of injury, central neuronal sensitivity (central hyperalgesia) in spinal and supraspinal regions innervating the injured area, and inflammatory changes triggered by the central nervous system. Recommended methods to prevent CPMP include careful dissection, reduction of inflammatory responses, and the use of minimally invasive surgical techniques to prevent peripheral and central neuronal sensitization.
Epidemiological studies-both retrospective and prospective-have identified some of these risk factors, such as younger age, chemotherapy, radiotherapy, and the presence of preoperative pain or severe acute postoperative pain. Unfortunately, there are few studies on this topic, and the literature needs further support.
The hypothesis in this study is that if investigator can identify the factors that increase chronic pain after mastectomy, investigator can take measures against these factors and reduce the development of chronic pain. Therefore, this study aims to identify the factors contributing to chronic pain after mastectomy.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 18-80
- •BMI 18-35 kg/m2
- •ASA (American Society of Anesthesiologists) Scoring I-II-III
- •Elective mastectomy surgery
- •Elective mastectomy and axillary dissection surgery
- •Patients who will undergo general anesthesia
- •Patients who agree to participate in the study and sign a form
排除标准
- •Patients under 18 and over 80 years of age
- •Patients who do not want to participate in the study
- •Patients with chronic pain or chronic opioid use
- •Patients with alcohol, substance or drug addiction
- •Patients with a history of previous mastectomy
- •Patients with limited cooperation such as dementia, psychiatric disorders
- •Pregnant and breastfeeding patients will be excluded from the study
- •Patients who cannot communicate in their native language will be excluded from the study
结局指标
主要结局
Self-leeds assessment of neuropathic symptoms and sign findings in 3rd months.
时间窗: Postoperative 3rd month
Patients; self-Leeds assessment of neuropathic symptoms and sign (S-LANSS) findings will be evaluated in the 3rd postoperative month. Patients with an S-LANSS score of 12 and above will be diagnosed with chronic neuropathic pain. In this scoring, the patient can get at least 0 points. He can get a maximum of 24 points. If the patient's score is 12 or above, the possibility of neuropathic pain is considered high.
次要结局
- Short Form 12 questionnaire in the 3rd month(Postoperative 3rd month)
- Short Form 12 questionnaire in the 6th month(Postoperative 6th month)
- Self-leeds assessment of neuropathic symptoms and sign findings at 6th months(Postoperative 6th month)
- Acute pain score(Up to 24 hours after the operation)
研究者
Berkant Demiray
Principal Investigator
Ankara Etlik City Hospital