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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04228705
Other study ID # 2019PHB258-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 13, 2019
Est. completion date December 12, 2020

Study information

Verified date January 2020
Source Peking University People's Hospital
Contact Feng Yi, MD, PhD
Phone 86-010-88325590
Email yifeng65@sina.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 6000
Est. completion date December 12, 2020
Est. primary completion date December 12, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Locations

Country Name City State
China Peking University People's Hospital Beijing Beijing

Sponsors (4)

Lead Sponsor Collaborator
Peking University People's Hospital Chinese PLA General Hospital, First Affiliated Hospital of Guangxi Medical University, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Outcome of 6-mins-walking test Walking distance of 6 minutes 1, 3, 7, 14, 21, 30, 60, 90, 120, 150 and180 days postoperation
Secondary Postoperative duration of stay in hospital The duration when patients stay in hospital after surgery. 30 days postoperation
Secondary Number of readmission within 30 days after surgery Readmission indicates unplanned readmission after hospital discharge. Up to 30 days postoperation
Secondary Complications within 30 days after surgery Complications within 30 days after surgery will be classified using Clavien-Dindo Classification of Surgical Complications, ranging from Grade I(Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions) to Grade V(death of a patient). Up to 30 days postoperation
Secondary The trajectories of health related quality of life(HRQoL) The trajectory of HRQoL is the vector of Utility values measured with EuroQol five-dimensional questionnaire(EQ-5D)taken over 6 months(days 1, 3, 7,14, 21, 30, 60, 90, 120, 150,180; Day 0 is the day of surgery). The EQ-5D measures health on five domains (mobility, self-care, usual activities, pain discomfort, and anxiety-depression), and the scores will be combined using Chinese general population weights to generate a single utility or index score. Utility values for the EQ-5D range from 1.00 to -0.391, where a score of 0 and 1 are regarded as equivalent to death and 'perfect health', respectively, and a score < 0 is considered as health state that is 'worse than death'. 1, 3, 7, 14, 21, 30, 60, 90, 120, 150 and180 days postoperation
Secondary Ambulation time The first time when patients can get off of bed and walk after surgery Up to 30 days postoperation
Secondary Oral feeding time The first time when patients begin oral feeding after surgery Up to 30 days postoperation
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