Clinical trial NCT06136663: Prevalence and Risk Factors for Postsurgical Pain After the Open Reduction and Internal Fixation of Lower Limbs.
Official title: A Prospective Cohort Survey on Prevalence and Risk Factors for Persistent Postsurgical Pain After the Open Reduction and Internal Fixation of the Lower Limbs
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Chronic Post Operative Pain
Lead sponsor: Xuzhou Central Hospital
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to trauma center for lower fracture (femur, tibia, patella, or foot/ankle) requiring open-reduction internal fixation were screened for inclusion between January 2020 and March 2023. Demographic questions are completed at the time of consent, and the mechanism of injury, primary injury location, body mass index, blood and urine assessments are extracted from each individual's medical record. Additionally, at 3 months each participant was asked whether they had developed chronic pain and completed a validated measure of self-reported pain intensity.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Refusing to participate in this study.

Primary outcomes:
measure: Postoperative chronic pain：pain score
timeFrame: Through study completion, an average of 1 year
measure: Perioperative inflammatory state
timeFrame: Up to 10 days
measure: Lifestyle and behaviour of the subjects
timeFrame: Baseline
measure: Preoperative complications of the participants
timeFrame: Baseline
measure: Medical interventions history
timeFrame: Up to 10 days
measure: Surgery details
timeFrame: Baseline
measure: Anesthesia during surgery
timeFrame: Baseline
measure: Age
timeFrame: Baseline
measure: Body mass index (BMI)
timeFrame: Baseline
measure: Gender
timeFrame: Baseline
measure: Cultural background
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
state: Jiangsu
Study officials:
References:
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