Peripheral Blood Single Cell Sequencing Analysis of POD and CPSP in Elderly Patients After Total Knee Arthroplasty

Peripheral Blood Single Cell Sequencing Analysis of Postoperative Delirium (POD) and Chronic Postsurgical Pain (CPSP) in Elderly Patients After Total Knee Arthroplasty

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Delirium; Chronic Postsurgical Pain

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.

• Study Type: Observational
• Enrollment (Anticipated): 10

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 80 years (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective total knee replacement.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
POD group; According to the occurrence of postoperative delirium, the patients were divided into POD group and non-POD group
non-POD group; According to the occurrence of postoperative delirium, the patients were divided into POD group and non-POD group
CPSP group; Patients were divided into CPSP group and non-CPSP group according to the occurrence of postoperative chronic pain
non-CSP group; Patients were divided into CPSP group and non-CPSP group according to the occurrence of postoperative chronic pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference of single cell sequencing before and after surgery	Leukocytes were isolated from peripheral blood and then sorted for subsequent single-cell sequencing analysis. Unbiased, high-throughput and high-resolution transcriptome analysis of single cells can reveal the gene structure and gene expression status of single cells, reflect the heterogeneity between cells, classify and analyze them, and carry out personalized research	1 day before surgery，1 day after surgery
3-minute Diagnostic Interview for CAM (3D-CAM)	Postoperative delirium was assessed by 3-minute Diagnostic Interview for confusion assessment method (CAM).	Consecutive 7 days after the surgery
Visual analogue scale（VAS）	A moving scale measuring about 10cm in length was used, with 10 scales on one side and "0" and "10" ends, respectively, with 0 indicating no pain and 10 indicating the most severe pain that could not be endured.	3 months after the surgery
Short form McGill pain questionnaire（SF-MPQ）	SF-MPQ is composed of sensory and emotional descriptors of pain, current pain intensity and visual analogue scale.	3 months after the surgery
Leeds Assessment of Neuropathic Symptoms and Signs（LANSS）	Make the needle perpendicular to the patient's skin, and apply different pressure on the skin to determine whether the patient has touch-induced pain.	3 months after the surgery
Pain catastrophizing scale(PCS)	PCS is defined as a belief system, a coping strategy and an evaluation process when experiencing and feeling pain.	3 months after the surgery

Collaborators and Investigators

• Sponsor: Xuzhou Central Hospital
• Collaborators: The Affiliated Hospital of Xuzhou Medical University
• Investigators: Study Director: Junli Cao, Doctor, Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University; Study Chair: Daqing Ma, Doctor, Imperial College London, Chelsea and Westminster Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 30, 2022
• Primary Completion (ANTICIPATED): October 30, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: September 29, 2022
• First Submitted That Met QC Criteria: October 5, 2022
• First Posted (ACTUAL): October 7, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 7, 2022
• Last Update Submitted That Met QC Criteria: October 5, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Pain, Postoperative; Delirium
• Other Study ID Numbers: XuzhouCH20221010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No