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Post Surgical PainHRQoLNCT03926858

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

An observational study of Post Surgical Pain, run by Peking University People's Hospital at 23 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Post Surgical Pain
How many people
2,000 participants
Where
23 sitesChina
Study dates
12 Jun 2019to 8 May 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

China23 sites

  • The Affiliated Hospital of Inner Mongolia Medical University

    Baotou, Inner Mongolia

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

  • Xiyuan Hospital

    Beijing

  • The First Hospital of Changsha

    Changsha, Hunan

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan

  • West China Hospital

    Chengdu, Sichuan

  • The Ninth People's Hospital of Chongqing

    Chongqing

  • Hangzhou Red Cross Hospital

    Hangzhou, Zhejiang

  • Tongde Hospital of Zhejiang Province

    Hangzhou, Zhejiang

  • Huhhot First Hospital

    Hohhot, Inner Mongolia

  • The First People's Hospital of Liangshan Yi Autonomous Prefecture

    Liangshan, Yunan

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi

  • Nanjing First Hospital

    Nanyang, Jiangsu

  • Huadong Hospital Affiliated to Fudan University

    Shanghai

  • Songyuan Central Hospital

    Songyuan, Jilin

  • Shanxi Provincial People's Hospital

    Taiyuan, Shanxi

  • The Second Hospital of Tianjin Medical University

    Tianjin

  • First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang

  • The Third People's Hospital of Hubei Province

    Wuhan, Hubei

  • Tongji Hospital

    Wuhan, Hubei

  • Xingtai People's Hospital

    Xingtai, Hebei

  • People's Hospital of Yuxi

    Yuxi, Yunnan

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

Other trials in China

About this study

Official title: 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.

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.

Keywords
post-surgical pain, health-related quality of life
Medical subject headings
Pain, Postoperative

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Health related quality of life(HRQoL)

    HRQoL is measured with EuroQol five-dimensional questionnaire(EQ-5D).

    Measured: up to 6 months after surgery

  2. Pain after surgery

    Postsurgical pain is measured with the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) .

    Measured: up to 6 months after surgery

Secondary outcomes (2)

  1. ambulation time

    the first time when patients can get off of bed and walk after surgery

    Measured: up to 30 days after surgery

  2. oral feeding time

    the first time when patients begin oral feeding after surgery

    Measured: up to 30 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2019
  2. Study start12 Jun 2019
  3. Primary completion8 May 2023
  4. Study completion8 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03926858
Sponsor's protocol ID
2018PHB229-01
Acronym
HRQoL
Status last verified
Jun 2024
First submitted
17 Apr 2019
Last updated
5 Jun 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

  • Zhang Q, Wu Y, Hong S, Feng Y. Trajectory of worst pain within the first two weeks following pelvic and sacral tumor surgery and long-term outcome: a pilot observational prospective cohort study. BMC Anesthesiol. 2023 Mar 9;23(1):73. doi: 10.1186/s12871-023-02033-z.

    PubMed 36894887

Questions about this trial

What is this clinical trial studying?

An observational study of Post Surgical Pain, run by Peking University People's Hospital at 23 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health related quality of life(HRQoL) (time frame: up to 6 months after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03926858, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2024.

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