Epidemiology Study and Risk Factor Analysis on Chronic Post-surgical Pain After Video-assisted Thoracic Surgery

NCT05473728 | Completed DMC

• 1 other identifier: ZS-3560
• Study Type: observational
• Target: 886
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a nationwide multi-center study to investigate the incidence and risk factors of chronic post-surgical pain (CPSP) after receiving video-assisted thoracic surgery (VATS). Patients receiving VATS in participating centers across China in Aug. 2022 will be assessed for eligibility, and all the enrolled patients will be followed up for at least 6 months. The study's primary outcome is the incidence of CPSP 6 months after VATS. Baseline demographic, psychological , surgical, anesthesia-related and pain-related characteristics will be evaluated for possible risk factors of CPSP after VATS.

Conditions

Pain, Postoperative

Keywords

Video-assisted thoracic surgery; Chronic post-surgical pain; Epidemiology study; risk factors

Outcome Measures

Primary Outcomes (1)

• post-surgical pain-6 month

  Asking patients about the existence of chronic pain related to surgery by telephone interview

  6 month after the VATS

Secondary Outcomes (2)

• post-surgical pain-3 month

  3 month after the VATS

• Influence on quality of life

  3\6 month after the VATS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Our research focuses on the incidence of CPSP after VATS in Chinese population. So, our target population will be all the Chinese patients receiving VATS in China. To select an accessible population that can well represent the target population, we set geographic criteria as regional medical centers in all seven geographical subregions of China, namely northwestern China, northern China, northeastern China, central China, southern China, southwestern China and southeastern China. Considering the needed sample size and the cost, we set time criteria as one month. Therefore, the accessible population in our study is all the patients receiving VATS in Aug., 2022 at selected medical centers in all seven geographical subregions of China.

You may qualify if:

• In-patients at participating medical centers
• Scheduled for unilateral VATS during the study enrollment period

You may not qualify if:

• Emergency surgeries
• Patients with known pain sensory impairment
• Patients cannot express themselves so that an NRS score cannot be measured

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator
• Tianjin Medical University Cancer Institute and Hospital: collaborator
• First Affiliated Hospital of Chongqing Medical University: collaborator
• Xiangya Hospital of Central South University: collaborator
• Shanghai Chest Hospital: collaborator
• The Affiliated Hospital of Inner Mongolia Medical University: collaborator
• The people's hospital of Xinjiang: collaborator
• Cancer hospital affiliated to Xinjiang Medical Universtity: collaborator
• Gansu provincial hospital of TCM: collaborator
• Tibet Autonomous Region People's Hospital: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

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

• Le Shen, M.D., Ph.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 24, 2022
• First Posted: July 26, 2022
• Study Start: August 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: June 30, 2023
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)