Establishment and Validation of Early-warning Model of Perioperative Pain for the Elders

NCT04228705 | Unknown

• 1 other identifier: 2019PHB258-01
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study will collect perioperative pain-related data of elderly patients in multi-centers. Analyzing these collected data to find the high-risk factors of postoperative pain in elderly patients and to establish an early-warning model of perioperative pain in elderly patients, so as to improve the ability of assessing the risks of postoperative pain in elderly patients and providing an early warning.

Conditions

Postoperative Pain; Pain Assessment; Elderly; Model

Outcome Measures

Primary Outcomes (2)

• Pain trajectories after surgery

  The pain trajectory is the vector of mean pain severity domain score (from 0 to 10) measured with pain severity domain of the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R)

  within 6 months

• Pain trajectories after surgery

  The pain trajectory is the vector of mean pain severity domain score (from 0 to 10) measured with Brief Pain Inventory -Short Form (BPI-SF) within 6 months

  within 6 months

Secondary Outcomes (7)

• Outcome of 6-mins-walking test

  1, 3, 7, 14, 21, 30, 60, 90, 120, 150 and180 days postoperation

• Postoperative duration of stay in hospital

  30 days postoperation

• Number of readmission within 30 days after surgery

  Up to 30 days postoperation

• Complications within 30 days after surgery

  Up to 30 days postoperation

• The trajectories of health related quality of life(HRQoL)

  1, 3, 7, 14, 21, 30, 60, 90, 120, 150 and180 days postoperation

Study Arms (2)

The elders

Patients aged over 59 years old

The young adults

Patients aged from 18 to 59 years old

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients aged 18 years or older undergoing general or regional anesthesia of any procedures, mainly include: breast surgery, thoracic surgery, abdominal surgery, total knee or hip replacement surgery and spine surgery.

You may qualify if:

• years or older
• Undergoing general or regional anesthesia
• Hospitalized for at least 24 hours after surgery
• Able to give informed consent
• Able to read and write

You may not qualify if:

• Existing diagnoses of psychiatric or neurologic pathology
• A history of substance abuse
• Admitted to ICU after surgery
• Patients with advanced tumors who have received preoperative chemotherapy or who are expected to receive postoperative chemotherapy.

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Chinese PLA General Hospital: collaborator
• First Affiliated Hospital of Guangxi Medical University: collaborator
• Zhejiang University: collaborator

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Feng Yi, MD, PhD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Yi, MD, PhD

CONTACT

86-010-88325590; yifeng65@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of department of anesthesiology and pain management

Study Record Dates

• First Submitted: January 12, 2020
• First Posted: January 14, 2020
• Study Start: December 13, 2019
• Primary Completion: December 12, 2020
• Study Completion: December 12, 2020
• Last Updated: January 14, 2020

Record last verified: 2020-01

Locations

CN (1)