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

NCT05572307 | Unknown DMC

• 1 other identifier: XuzhouCH20221010
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Delirium; Chronic Postsurgical Pain

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (4)

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

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective total knee replacement.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xuzhou Central Hospital: lead
• The Affiliated Hospital of Xuzhou Medical University: collaborator

Study Sites (1)

Xuzhou Central Hospital

Xuzhou, Jiangsu, 221000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Nucleated cells from peripheral blood were extracted and frozen.These cells are destroyed after single-cell sequencing.

MeSH Terms

Conditions

Emergence Delirium; Pain, Postoperative

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Pain

Study Officials

• Yangzi Zhu, Doctor

  Xuzhou Central Hospital

  PRINCIPAL INVESTIGATOR

• Liwei Wang, Doctor

  Xuzhou Central Hospital

  STUDY DIRECTOR

• Junli Cao, Doctor

  Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University

  STUDY DIRECTOR

• Daqing Ma, Doctor

  Imperial College London, Chelsea and Westminster Hospital

  STUDY CHAIR

Central Study Contacts

Yangzi Zhu, Doctor

CONTACT

+86 18168779150; zhuyz@188.com

Liwei Wang, Doctor

CONTACT

+86 18952170255; doctorlww@sina.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 7, 2022
• Study Start: October 30, 2022
• Primary Completion: October 30, 2023
• Study Completion: December 31, 2023
• Last Updated: March 8, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)