跳至主要内容
临床试验/NCT06136663
NCT06136663Enrolling By Invitation不适用

A Prospective Cohort Survey on Prevalence and Risk Factors for Persistent Postsurgical Pain After the Open Reduction and Internal Fixation of the Lower Limbs

Xuzhou Central Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2023年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
1,000
试验地点
1
主要终点
Postoperative chronic pain:pain score

研究概览

简要总结

The objective of this study is to specify the demographic and medical factors that most likely constitute a risk of developing CPSP in the patients with lower limb.

详细描述

Chronic pain,one of the most frequent causes for patients to seek medical care,is a recognized health problem.Chronic postsurgical pain (CPSP), commonly defined as pain that develops after a surgical procedure and persists at least 3 months, constitutes a widely underdiagnosed and often poorly treated medical problem affecting 10-50% of all postsurgical patients. According to the reports,in the United States alone,1.9 million persons abused or were dependent on prescription opioid analgesics for chronic pain in 2013,contributing to one of the worst public health crises the developed world has recently faced.Here,open reduction and internal fixation(ORIF) of lower limb fractures ,what the investigators focus, is a common surgical procedure in orthopedics and microscopic hand and foot surgery.The removal of the intramedullary nail can relieve anterior knee pain, but in a substantial number of patients, pain persists after nail removal.The most painful daily activities are kneeling and squatting.Therefore, it is increasingly important and urgent to solve the postoperative chronic pain of patients with lower extremity fractures surgery.

The underlying biology of chronic postoperative pain and genetic heritability is complex and not yet fully understood . A common feature of CPSP is that the painful sensations change from the familiar acute postoperative pain to a complex pain syndrome with nonaplastic characteristics,neuropathic characteristics, or both. Preclinical studies have revealed that neuroinflammation is one of pathological hallmarks of CPSP. The transition from acute to chronic pain starts early within the first 2 weeks after nonaplastic by peripheral and central inflammatory processes and activation of spinal glial cells.Repetitive nociception resulting from prolonged inflammatory and neuropathic responses to noxious stimuli causes a cascade of biochemical and structural changes to various pain pathways resulting in sensitization of the peripheral and central nervous system(CNS). Cytokines and neurotrophic factors have been identified as pivotal mediators involved in neuroimmune activation pathways and cascades in various preclinical chronic pain models.

Although lower limb fracture is one of the most frequently reported triggering CPSP events, few large-scale studies have shown the occurrence of and factors associated with it.The objectives of investigators are to specify the demographic and medical factors that most likely constitute a risk of developing CPSP and to search for potential interventions to reduce the occurrence of CPSP in these limb fracture patients.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Underwent surgical repair including fracture of the lower leg, fracture of the foot and fractures involving multiple regions of the lower limbs.

排除标准

  • Refusing to participate in this study.

结局指标

主要结局

Postoperative chronic pain:pain score

时间窗: Through study completion, an average of 1 year

1. Postoperative chronic pain assessed by the Numerical Rating Scale (NRS). Pain score \>=3 at operational areas (minimum 0, maximum 10, higher score indicates greater pain). 2. Pain developed after a surgical procedure or increased in intensity after the surgical procedure. 3. Pain should be of at least 3 months duration with a significant negative effect on the quality of life. 4. Pain is a continuation of acute postoperative pain or may develop after an asymptomatic period and pain is localized to the surgical field or to a referred area (eg, innervation territory, referred dermatome for visceral surgery). 5. Other possible causes for the pain have been excluded (eg, infection, cancer recurrence)

Age

时间窗: Baseline

The age of each subject in the operating room was counted.

Body mass index (BMI)

时间窗: Baseline

The BMI of each subject in the operating room was counted and compared.

Preoperative complications of the participants

时间窗: Baseline

Including cardiovascular and cerebrovascular diseases (such as hypertension, coronary heart disease), respiratory diseases (such as chronic obstructive pulmonary disease), endocrine system diseases (such as diabetes, hyperthyroidism) and so on.

Surgery details

时间窗: Baseline

Including specific surgical site (femur, tibia or fibula or multiple injuries) ,the time of operation, the amount of bleeding during operation,etc.

Gender

时间窗: Baseline

The gender ratio of the CPSP group and pain-free group was recorded and compared.

Lifestyle and behaviour of the subjects

时间窗: Baseline

Through the electronic medical record system and telephone follow-up, to understand whether there is a history of smoking, drinking, physical activity.

Anesthesia during surgery

时间窗: Baseline

The types of anesthesia (general anesthesia, spinal anesthesia and whether to use nerve block, etc. )

Perioperative inflammatory state

时间窗: Up to 10 days

The inflammatory factors,C-reactive protein(CRP), white blood cell count, and lymphocyte ratio of the subjects were counted.

Medical interventions history

时间窗: Up to 10 days

The use of the analgesic drugs, including the past and this perioperative period

Cultural background

时间窗: Baseline

Record the highest academic qualifications of the subjects.

次要结局

未报告次要终点

研究者

发起方
Xuzhou Central Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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