Clinical trial NCT03926858: Patient-reported Outcomes of Postsurgical Pain and Health Related Quality of Life
Official title: Patient-reported Outcomes of Postsurgical Pain and Health Related Quality of Life, a Multi-centered, Prospective, Observational, Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Surgical Pain
Keywords: post-surgical pain
health-related quality of life
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2019-04-25
Enrollment: 2000
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 undergoing the following procedures: breast surgery, thoracic surgery, abdominal surgery, orthopedic surgery.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Health related quality of life(HRQoL)
timeFrame: up to 6 months after surgery
measure: Pain after surgery
timeFrame: up to 6 months after surgery
Secondary outcomes:
measure: ambulation time
timeFrame: up to 30 days after surgery
measure: oral feeding time
timeFrame: up to 30 days after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Xingtai
country: China
facility: Xingtai People's Hospital
state: Hebei
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: The Third People's Hospital of Hubei Province
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
city: Changsha
country: China
facility: The First Hospital of Changsha
state: Hunan
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Baotou
country: China
facility: The Affiliated Hospital of Inner Mongolia Medical University
state: Inner Mongolia
city: Hohhot
country: China
facility: Huhhot First Hospital
state: Inner Mongolia
city: Nanyang
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Songyuan
country: China
facility: Songyuan Central Hospital
state: Jilin
city: Taiyuan
country: China
facility: Shanxi Provincial People's Hospital
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
city: Urumqi
country: China
facility: First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Liangshan
country: China
facility: The First People's Hospital of Liangshan Yi Autonomous Prefecture
state: Yunan
city: Yuxi
country: China
facility: People's Hospital of Yuxi
state: Yunnan
city: Hangzhou
country: China
facility: Hangzhou Red Cross Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Tongde Hospital of Zhejiang Province
state: Zhejiang
city: Beijing
country: China
facility: Xiyuan Hospital
city: Chongqing
country: China
facility: The Ninth People's Hospital of Chongqing
city: Shanghai
country: China
facility: Huadong Hospital Affiliated to Fudan University
city: Tianjin
country: China
facility: The Second Hospital of Tianjin Medical University
Study officials:
affiliation: Peking University People's Hospital
name: Yi Feng, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Xiyuan Hospital
name: Xiumei Gao, MD
role: STUDY_DIRECTOR
affiliation: Tianjin Medical University Second Hospital
name: Jingzhi Liu
role: STUDY_DIRECTOR
affiliation: Songyuan Central Hospital
name: Guanghe Si, MD
role: STUDY_DIRECTOR
affiliation: The Affiliated Hospital of Inner Mongolia Medical University
name: Yaying Xie
role: STUDY_DIRECTOR
affiliation: Huhhot First Hospital
name: Jun Yan
role: STUDY_DIRECTOR
affiliation: Yantai Yuhuangding Hospital
name: Aizhi Li
role: STUDY_DIRECTOR
affiliation: Shanxi Provincial People's Hospital
name: Weiwei Zhang, MD
role: STUDY_DIRECTOR
affiliation: Xingtai People's Hospital
name: Zhenhua Qu, MD
role: STUDY_DIRECTOR
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Ying Wang, MD
role: STUDY_DIRECTOR
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Hongguang Bao
role: STUDY_DIRECTOR
affiliation: Huadong Hospital
name: Weidong Gu
role: STUDY_DIRECTOR
affiliation: Red Cross Hospital, Hangzhou, China
name: Fan Tao
role: STUDY_DIRECTOR
affiliation: Zhejiang Provincial Tongde Hospital
name: Hongwei Wang
role: STUDY_DIRECTOR
affiliation: Tongji Hospital
name: Xianwei Zhang
role: STUDY_DIRECTOR
affiliation: The Third People's Hospital of Hubei Province
name: Qingpeng Dong
role: STUDY_DIRECTOR
affiliation: The Third Xiangya Hospital of Central South University
name: Qin Liao
role: STUDY_DIRECTOR
affiliation: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
name: Caiping Liao
role: STUDY_DIRECTOR
affiliation: Guangdong Second Provincial Central Hospital
name: Haihua Shu
role: STUDY_DIRECTOR
affiliation: Guilin Medical University, China
name: Zhijun Chen
role: STUDY_DIRECTOR
affiliation: First Affiliated Hospital of Guangxi Medical University
name: Yubo Xie
role: STUDY_DIRECTOR
affiliation: West China Hospital
name: Bangxiang Yang
role: STUDY_DIRECTOR
affiliation: The Ninth People's Hospital of Chongqing
name: Hui Huang
role: STUDY_DIRECTOR
affiliation: The First People's Hospital of Liangshan Yi Autonomous Prefecture
name: Xiang Shen
role: STUDY_DIRECTOR
affiliation: People's Hospital of Yuxi
name: Shaoxing Dong
role: STUDY_DIRECTOR
affiliation: First Affiliated Hospital of Xinjiang Medical University
name: Yimei Li
role: STUDY_DIRECTOR
References:
citation: Gan TJ, Habib AS, Miller TE, White W, Apfelbaum JL. Incidence, patient satisfaction, and perceptions of post-surgical pain: results from a US national survey. Curr Med Res Opin. 2014 Jan;30(1):149-60. doi: 10.1185/03007995.2013.860019. Epub 2013 Nov 15.
citation: Taylor RS, Ullrich K, Regan S, Broussard C, Schwenkglenks M, Taylor RJ, Gordon DB, Zaslansky R, Meissner W, Rothaug J, Langford R; PAIN-OUT investigators. The impact of early postoperative pain on health-related quality of life. Pain Pract. 2013 Sep;13(7):515-23. doi: 10.1111/papr.12026. Epub 2012 Dec 23.