NCT03808220

Brief Summary

PAIN OUT is a multi-national, non-interventional registry and benchmark project, assessing and analysing clinical and patient-reported outcome data of postoperative pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,197

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 14, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 17, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

January 20, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2021

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

2.5 years

First QC Date

January 14, 2019

Last Update Submit

May 14, 2024

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Questionnaire on postoperative pain treatment

    first postoperative day

Secondary Outcomes (1)

  • Questionnaire on patients' perception of pain treatment outcome

    first postoperative day

Study Arms (2)

post-surgical patients

post-surgical patients \> 18 years

Behavioral: postoperative pain intensityBehavioral: preoperative pain frequencyBehavioral: Side effect

pediatric patients post-op day 1

pediatric patients \> 4 years on post-op day 1 (sub-project QUIPSI - PAIN OUTinfant)

Behavioral: postoperative pain intensityBehavioral: preoperative pain frequencyBehavioral: Side effect

Interventions

postoperative pain intensityBEHAVIORAL

estimate the postoperative pain intensity by using a scaling system via questionnaire

pediatric patients post-op day 1post-surgical patients
preoperative pain frequencyBEHAVIORAL

estimate the preoperative pain intensity by using a scaling system via questionnaire

pediatric patients post-op day 1post-surgical patients
Side effectBEHAVIORAL

investigate the presence of any side effect

pediatric patients post-op day 1post-surgical patients

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

adult post-surgical patients in hospitals on post-op day 1

You may qualify if:

  • \>= 18 years or \>= 4 years for sub-project QUIPSI/PAIN OUTinfant
  • patient is post-op day 1
  • patient is at least 6 hours on the ward
  • patient has given consent

You may not qualify if:

  • patient cannot communicate
  • patient is cognitively impaired
  • patient is asleep
  • patient is too ill
  • patient does not want to fill in the questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Psychology

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Behavioral SciencesBehavioral Disciplines and Activities

Study Officials

  • Winfried Meissner

    Jena University Hospital

    STUDY DIRECTOR

  • Chi Wai Cheung, MD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Cheung Chi Wai

Study Record Dates

First Submitted

January 14, 2019

First Posted

January 17, 2019

Study Start

January 20, 2019

Primary Completion

July 26, 2021

Study Completion

July 26, 2021

Last Updated

May 16, 2024

Record last verified: 2024-05

Locations

HK(1)