NCT03363672

Brief Summary

Chronic postoperative pain (CPP) remains a disturbing and obscure clinical problem, which could last for more than 3 months after surgery. The aim of present study was to assess the prevalence of CPP, investigate its impact on life quality and explore its potential risk factors. After informed consent was signed, patients receiving surgery under general anesthesia in Peking Union Medical College Hospital and other medical centers participating in this study during 2018 will be included. Patients' preoperative information will be collected from medical record, including basic demographic data, primary disease and previous chronic diseases. Intraoperative information will be obtained from anesthesia record, including surgical scope, duration, length and location of incisions and blood loss. Acute pain will be evaluated in the ward of the department of surgery, when an app will be installed on patients' mobile phones. Our long-term postoperative follow-up would be performed by sending out survey questionnaires via this app in the 4th, 8th, 16th, 32th, and 48th weeks after surgery. The survey covers questions regarding the intensity, characteristic, location and impact on daily activities of CPP. Information regarding treatment of CPP will also be collected, if any. All the data gained will be summarized in our database and analyzed.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 6, 2017

Completed
26 days until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

December 6, 2017

Status Verified

November 1, 2017

Enrollment Period

2 years

First QC Date

November 20, 2017

Last Update Submit

November 30, 2017

Conditions

Keywords

Chronic Postoperative PainDaily LifeRisk Factor

Outcome Measures

Primary Outcomes (1)

  • The prevalence of chronic postoperative pain

    The prevalence of chronic postoperative pain reported by the included patients in the questionnaire issued by app

    24 weeks postoperatively

Secondary Outcomes (4)

  • The prevalence of chronic postoperative pain

    4,8,12,16,20,32,40,48 weeks postoperatively

  • Wong-Baker Faces Pain Rating Scale

    4,8,12,16,20,24,32,40,48 weeks postoperatively

  • Characteristics and location of chronic postoperative pain

    4,8,12,16,20,24,32,40,48 weeks postoperatively

  • Brief Pain Index

    4,8,12,16,20,24,32,40,48 weeks postoperatively

Study Arms (1)

Patients receiving surgery

No intervention will be administered. Patients included will be asked to return a questionnaire regarding chronic postoperative pain via app.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients receiving surgery under general anesthesia during 2018 in Peking Union Medical College Hospital and other medical centers participating in this study

You may qualify if:

  • Patients receiving surgery under general anesthesia during 2018 in Peking Union Medical College Hospital and other medical centers participating in this study.
  • Aged 18-70 years.

You may not qualify if:

  • Previous surgery history;
  • Preoperative chronic pain history;
  • Injury;
  • Have no access to mobile phone or website;
  • Postoperative chronic infection;
  • Non-radical incision of tumor or malignancy recurrence during follow-up;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Yuguang Huang, MD.

    Peking Union Medical College Hospital

    STUDY CHAIR

Central Study Contacts

Yuguang Huang, MD.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
48 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman of anesthesisology department

Study Record Dates

First Submitted

November 20, 2017

First Posted

December 6, 2017

Study Start

January 1, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

December 6, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will share

IPD will be shared via a database.

Time Frame
IPD will become available from 2018-1-1 to 2019-12-31.
Access Criteria
All the IPD will be included in a public database shared by all the medical centers participating in this study.