Clinical trial NCT04228705: Establishment and Validation of Early-warning Model of Perioperative Pain for the Elders
Official title: Study on Comprehensive Strategy of Perioperative Pain Prevention and Treatment in Elderly Patients -- Establishment and Validation of Early-warning Model of Perioperative Pain for the Elders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Pain
Pain Assessment
Elderly
Model
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Chinese PLA General Hospital
name: First Affiliated Hospital of Guangxi Medical University
name: Zhejiang University
First posted: 2020-01-14
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: This study will collect perioperative pain-related data of elderly patients in multi-centers, including: preoperative general data, intraoperative anesthesia and surgical data, clinical laboratory data, postoperative pain and intervention, postoperative complications and quality of life. 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.

Eligibility criteria: Inclusion Criteria:

* 18 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Pain trajectories after surgery
timeFrame: within 6 months
measure: Pain trajectories after surgery
timeFrame: within 6 months
Secondary outcomes:
measure: Outcome of 6-mins-walking test
timeFrame: 1, 3, 7, 14, 21, 30, 60, 90, 120, 150 and180 days postoperation
measure: Postoperative duration of stay in hospital
timeFrame: 30 days postoperation
measure: Number of readmission within 30 days after surgery
timeFrame: Up to 30 days postoperation
measure: Complications within 30 days after surgery
timeFrame: Up to 30 days postoperation
measure: The trajectories of health related quality of life(HRQoL)
timeFrame: 1, 3, 7, 14, 21, 30, 60, 90, 120, 150 and180 days postoperation
measure: Ambulation time
timeFrame: Up to 30 days postoperation
measure: Oral feeding time
timeFrame: Up to 30 days postoperation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Feng Yi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: