Patient-reported Outcomes of Postsurgical Pain and Health Related Quality of Life (HRQoL)

February 3, 2022 updated by: Yi Feng, MD, Peking University People's Hospital

Patient-reported Outcomes of Postsurgical Pain and Health Related Quality of Life, a Multi-centered, Prospective, Observational, Cohort Study

This study will investigate the impact of post-surgical pain (PSP) on health related quality of life (HRQoL) within the first six months following surgery using patient-reported outcome (PRO) measures, and to investigate medical recovery measures such as ambulation and oral feeding time as secondary outcomes.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Pain and recovery after surgery are extremely concerned by patients undergoing surgery. Though it is important to understand the recovery course of postsurgical pain and recovery, most previous studies just focused on one specific time point, and the results were inconsistent.

To investigate the impact of PSP on HRQoL within the first six months following surgery using PRO measures, patients undergoing several specific surgeries will be interviewed. Patients' medical charts will be reviewed by investigators to record sociodemographic and clinical data.

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Xiyuan Hospital
        • Contact:
          • Xiumei gao
      • Chongqing, China
        • Recruiting
        • The Ninth People's Hospital of Chongqing
        • Contact:
          • Hui Huang
      • Shanghai, China
        • Recruiting
        • Huadong Hospital affiliated to Fudan University
        • Contact:
          • Weidong Gu
      • Tianjin, China
        • Recruiting
        • The Second Hospital of Tianjin Medical University
        • Contact:
          • Jingzhi Liu
    • Beijing
      • Beijing, Beijing, China, 100044
        • Recruiting
        • Peking University People's Hospital
        • Contact:
          • Yi Feng
          • Phone Number: 010-88325581
    • Guangxi
      • Nanning, Guangxi, China
        • Recruiting
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
          • Yubo Xie
    • Hebei
      • Xingtai, Hebei, China
        • Recruiting
        • Xingtai People's Hospital
        • Contact:
          • Zhenhua Qu
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
          • Ying Wang
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Tongji Hospital
        • Contact:
          • Xianwei Wang
      • Wuhan, Hubei, China
        • Recruiting
        • The Third People's Hospital of Hubei Province
        • Contact:
          • qingpeng Dong
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • The Third Xiangya Hospital of Central South University
        • Contact:
          • Qin Liao
      • Changsha, Hunan, China
        • Recruiting
        • The First Hospital of ChangSha
        • Contact:
          • caiqin liao
    • Inner Mongolia
      • Baotou, Inner Mongolia, China
        • Recruiting
        • The Affiliated Hospital of Inner Mongolia Medical University
        • Contact:
          • Yaying Xie
      • Hohhot, Inner Mongolia, China
        • Recruiting
        • Huhhot First Hospital
    • Jiangsu
      • Nanyang, Jiangsu, China
        • Recruiting
        • Nanjing First Hospital
        • Contact:
          • Hongguang Bao
    • Jilin
      • Songyuan, Jilin, China
        • Recruiting
        • Songyuan Central Hospital
        • Contact:
          • Guanghe Si
    • Shanxi
      • Taiyuan, Shanxi, China
        • Recruiting
        • Shanxi Provincial People's Hospital
        • Contact:
          • Weiwei Zhang
    • Sichuan
      • Chengdu, Sichuan, China
        • Not yet recruiting
        • West China Hospital
        • Contact:
          • Bangxiang Yang
    • Xinjiang
      • Urumqi, Xinjiang, China
        • Recruiting
        • First Affiliated Hospital of Xinjiang Medical University
        • Contact:
          • Yimei Li
    • Yunan
      • Liangshan, Yunan, China
        • Recruiting
        • The First People's Hospital of Liangshan Yi Autonomous Prefecture
        • Contact:
          • xiang shen
    • Yunnan
      • Yuxi, Yunnan, China
        • Recruiting
        • People's Hospital of Yuxi
        • Contact:
          • Shaoxing Dong
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Hangzhou Red Cross Hospital
        • Contact:
          • Fan Tao
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Tongde Hospital of Zhejiang Province
        • Contact:
          • Hongwei Wang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients undergoing the following procedures: breast surgery, thoracic surgery, abdominal surgery, orthopedic surgery.

Description

Inclusion Criteria:

  • 18 years or older
  • Undergoing general or regional anesthesia
  • Hospitalized for at least 24 hours after surgery

Exclusion Criteria:

  • Existing diagnoses of psychiatric pathology
  • Surgery cancellation
  • Unable to give informed consent
  • Unable to read and write

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health related quality of life(HRQoL)
Time Frame: up to 6 months after surgery
HRQoL is measured with EuroQol five-dimensional questionnaire(EQ-5D).
up to 6 months after surgery
Pain after surgery
Time Frame: up to 6 months after surgery
Postsurgical pain is measured with the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) .
up to 6 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ambulation time
Time Frame: up to 30 days after surgery
the first time when patients can get off of bed and walk after surgery
up to 30 days after surgery
oral feeding time
Time Frame: up to 30 days after surgery
the first time when patients begin oral feeding after surgery
up to 30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Investigators

  • Principal Investigator: Yi Feng, PhD, Peking University People's Hospital
  • Study Director: Xiumei Gao, MD, Xiyuan Hospital
  • Study Director: Jingzhi Liu, Tianjin Medical University Second Hospital
  • Study Director: Guanghe Si, MD, Songyuan Central Hospital
  • Study Director: Yaying Xie, The Affiliated Hospital of Inner Mongolia Medical University
  • Study Director: Jun Yan, Huhhot First Hospital
  • Study Director: Aizhi Li, Yantai Yuhuangding Hospital
  • Study Director: Weiwei Zhang, MD, Shanxi Provincial People's Hospital
  • Study Director: Zhenhua Qu, MD, Xingtai People's Hospital
  • Study Director: Ying Wang, MD, The First Affiliated Hospital of Zhengzhou University
  • Study Director: Hongguang Bao, The First Affiliated Hospital with Nanjing Medical University
  • Study Director: Weidong Gu, Huadong Hospital
  • Study Director: Fan Tao, Red Cross Hospital, Hangzhou, China
  • Study Director: Hongwei Wang, Zhejiang Provincial Tongde Hospital
  • Study Director: Xianwei Zhang, Tongji Hospital
  • Study Director: Qingpeng Dong, The Third People's Hospital of Hubei Province
  • Study Director: Qin Liao, The Third Xiangya Hospital of Central South University
  • Study Director: Caiping Liao, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
  • Study Director: Haihua Shu, Guangdong Second Provincial Central Hospital
  • Study Director: Zhijun Chen, Guilin Medical University, China
  • Study Director: Yubo Xie, First Affiliated Hospital of Guangxi Medical University
  • Study Director: Bangxiang Yang, West China Hospital
  • Study Director: Hui Huang, The Ninth People's Hospital of Chongqing
  • Study Director: Xiang Shen, The First People's Hospital of Liangshan Yi Autonomous Prefecture
  • Study Director: Shaoxing Dong, People's Hospital of Yuxi
  • Study Director: Yimei Li, First Affiliated Hospital of Xinjiang Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2019

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

April 17, 2019

First Submitted That Met QC Criteria

April 23, 2019

First Posted (Actual)

April 25, 2019

Study Record Updates

Last Update Posted (Actual)

February 15, 2022

Last Update Submitted That Met QC Criteria

February 3, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018PHB229-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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