Clinical trial NCT05572307: Peripheral Blood Single Cell Sequencing Analysis of POD and CPSP in Elderly Patients After Total Knee Arthroplasty
Official title: Peripheral Blood Single Cell Sequencing Analysis of Postoperative Delirium (POD) and Chronic Postsurgical Pain (CPSP) in Elderly Patients After Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Delirium
Chronic Postsurgical Pain
Lead sponsor: Xuzhou Central Hospital
Sponsor class: OTHER
Collaborators: name: The Affiliated Hospital of Xuzhou Medical University
First posted: 2022-10-07
Enrollment: 10
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective total knee replacement.

Brief summary: Single-celled sequencing for evaluating differences in gene expression patterns in different cell types of the dynamics of a means of this research as a starting point, to study the postoperative delirium and chronic pain at the cellular level changes the contents of a cell, reveal its occurrence and development of the role of gene regulation, find targets and biomarkers, and to provide new ideas for its pathogenesis, To provide theoretical basis support for its prevention, clinical diagnosis and treatment.

Detailed description: The aim of this study was to investigate leukocyte heterogeneity in patients undergoing total knee arthroplasty with POD, paired non-POD patients, and cognitively normal healthy subjects by single cell sequencing, and to investigate leukocyte heterogeneity in patients with chronic pain and patients with pain relief after surgery through postoperative pain follow-up. Moreover, multi-omics single cell technology is used to analyze various cellular contents in a single cell simultaneously, which can capture molecular footprints with higher resolution. Comprehensive analysis of multiple omics datasets reveals the relationships between cellular patterns, establishes complex regulatory networks, and provides a holistic view of cellular state. From a single cell level analysis of POD and occurred in patients with chronic pain in patients with the characteristics of the white blood cells, looking for the peripheral immune system in the pathogenesis of the POD and the potential role of chronic pain occurs, may provide POD pathogenesis and chronic pain occurred an important visual Angle, may also help to provide POD biomarkers and therapeutic targets, To provide a possible solution for the prevention and treatment of postoperative delirium and postoperative chronic pain.

Eligibility criteria: Inclusion Criteria:

* Age ≥65 years old, regardless of gender.
* total knee arthroplasty for the first time.
* The ASA classification is I-Ⅲ.

Exclusion Criteria:

* severe neurological or psychiatric disorders
* drug and alcohol abuse
* patients on antidepressants
* failure and decompensation of vital organs
* chronic pain from previous surgery or trauma

Primary outcomes:
measure: Difference of single cell sequencing before and after surgery
timeFrame: 1 day before surgery，1 day after surgery
measure: 3-minute Diagnostic Interview for CAM (3D-CAM)
timeFrame: Consecutive 7 days after the surgery
measure: Visual analogue scale（VAS）
timeFrame: 3 months after the surgery
measure: Short form McGill pain questionnaire（SF-MPQ）
timeFrame: 3 months after the surgery
measure: Leeds Assessment of Neuropathic Symptoms and Signs（LANSS）
timeFrame: 3 months after the surgery
measure: Pain catastrophizing scale(PCS)
timeFrame: 3 months after the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
state: Jiangsu
Study officials:
affiliation: Xuzhou Central Hospital
name: Yangzi Zhu, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Xuzhou Central Hospital
name: Liwei Wang, Doctor
role: STUDY_DIRECTOR
affiliation: Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University
name: Junli Cao, Doctor
role: STUDY_DIRECTOR
affiliation: Imperial College London, Chelsea and Westminster Hospital
name: Daqing Ma, Doctor
role: STUDY_CHAIR
References: