CompletedNCT03926858HRQoLUpdated Jun 5, 2024

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

An observational study in Post Surgical Pain, sponsored by Peking University People's Hospital. Completed at 23 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-05.

Sponsored by Peking University People's Hospital · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 2,000
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Post Surgical Pain

Browse trials for

Pain, Postoperative 5,093

Keywords

post-surgical pain
health-related quality of life

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 2,000 is above the median of 102 across 608 observational studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 2,000 participants (actual)
Patient registry: No

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

23 sites

Peking University People's Hospital
Beijing, Beijing 100044, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Xingtai People's Hospital
Xingtai, Hebei, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
The Third People's Hospital of Hubei Province
Wuhan, Hubei, China
Tongji Hospital
Wuhan, Hubei, China
The First Hospital of Changsha
Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
The Affiliated Hospital of Inner Mongolia Medical University
Baotou, Inner Mongolia, China
Huhhot First Hospital
Hohhot, Inner Mongolia, China
Nanjing First Hospital
Nanyang, Jiangsu, China
Songyuan Central Hospital
Songyuan, Jilin, China
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, China
West China Hospital
Chengdu, Sichuan, China
First Affiliated Hospital of Xinjiang Medical University
Urumqi, Xinjiang, China
The First People's Hospital of Liangshan Yi Autonomous Prefecture
Liangshan, Yunan, China
People's Hospital of Yuxi
Yuxi, Yunnan, China
Hangzhou Red Cross Hospital
Hangzhou, Zhejiang, China
Tongde Hospital of Zhejiang Province
Hangzhou, Zhejiang, China
Xiyuan Hospital
Beijing, China
The Ninth People's Hospital of Chongqing
Chongqing, China
Huadong Hospital Affiliated to Fudan University
Shanghai, China
The Second Hospital of Tianjin Medical University
Tianjin, China

References and documents

Publications

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. PubMed 24237004 ↗
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. PubMed 23279591 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03926858
Lead sponsor: Peking University People's Hospital
Responsible party: Yi Feng, MD (Director of department of anesthesiology and pain management, Peking University People's Hospital) — Principal investigator
First posted: Apr 25, 2019
Start date: Jun 12, 2019
Primary completion: May 8, 2023
Completion: May 8, 2023
Last update: Jun 5, 2024

Study contacts

Yi Feng, PhD

principal investigator · Peking University People's Hospital

Xiumei Gao, MD

study director · Xiyuan Hospital

Jingzhi Liu

study director · Tianjin Medical University Second Hospital

Guanghe Si, MD

study director · Songyuan Central Hospital

Yaying Xie

study director · The Affiliated Hospital of Inner Mongolia Medical University

Jun Yan

study director · Huhhot First Hospital

Aizhi Li

study director · Yantai Yuhuangding Hospital

Weiwei Zhang, MD

study director · Shanxi Provincial People's Hospital

Zhenhua Qu, MD

study director · Xingtai People's Hospital

Ying Wang, MD

study director · The First Affiliated Hospital of Zhengzhou University

Hongguang Bao

study director · The First Affiliated Hospital with Nanjing Medical University

Weidong Gu

study director · Huadong Hospital

Fan Tao

study director · Red Cross Hospital, Hangzhou, China

Hongwei Wang

study director · Zhejiang Provincial Tongde Hospital

Xianwei Zhang

study director · Tongji Hospital

Qingpeng Dong

study director · The Third People's Hospital of Hubei Province

Qin Liao

study director · The Third Xiangya Hospital of Central South University

Caiping Liao

study director · The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

Haihua Shu

study director · Guangdong Second Provincial Central Hospital

Zhijun Chen

study director · Guilin Medical University, China

Yubo Xie

study director · First Affiliated Hospital of Guangxi Medical University

Bangxiang Yang

study director · West China Hospital

Hui Huang

study director · The Ninth People's Hospital of Chongqing

Xiang Shen

study director · The First People's Hospital of Liangshan Yi Autonomous Prefecture

Shaoxing Dong

study director · People's Hospital of Yuxi

Yimei Li

study director · First Affiliated Hospital of Xinjiang Medical University

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Pain, Postoperative→

Other studies from this sponsor

Peking University People's Hospital

Start the discussion