Prospective Observational Study on Postoperative Pain and Side Effect (Pain Out)

Improvement in Postoperative Pain Outcome

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

Study Overview

• Status: Active, not recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Behavioral: postoperative pain intensity; Behavioral: preoperative pain frequency; Behavioral: Side effect

Detailed Description

PAIN OUT offers a large registry as well as a system for benchmarking and feedback of outcome quality and decision support in acute pain conditions. It collects demographic, clinical and outcome data, using a validated assessment tool available in multiple languages.

The registry part of the project aims at performing population-based research. Furthermore, its infrastructure allows for the conduct of prospective studies comparing the effectiveness of processes of care.

The benchmark part of the project provides the medical community with a unique, user-friendly system to improve treatment of patients with postoperative pain. A web-based information system, featuring two main functions, was developed:

a feedback and benchmarking system which provides participating sites with continuously updating data and analyses about the quality of care they provide compared to other institutions and allows identification of best clinical practice.

a knowledge library which provides clinicians with easily accessible and regularly updated summaries of evidence-based recommendations tailored to specific post-operative situations.

From 2016 on, sub-projects in Mexico, China and several European countries have started. This programs take place over a period of two years during which collaborators carry out a Quality Improvement project in their hospital using methodology provided by PAIN OUT. This includes collection of baseline data in a first phase, analysis of findings according to a protocol provided by PAIN OUT, review of findings and developement of improvement measures, implementation of the improvements and assessment of outcomes after a second phase of data collection.

• Study Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • The University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• >= 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
post-surgical patients; post-surgical patients > 18 years	Behavioral: postoperative pain intensity; estimate the postoperative pain intensity by using a scaling system via questionnaire; Behavioral: preoperative pain frequency; estimate the preoperative pain intensity by using a scaling system via questionnaire; Behavioral: Side effect; investigate the presence of any 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 intensity; estimate the postoperative pain intensity by using a scaling system via questionnaire; Behavioral: preoperative pain frequency; estimate the preoperative pain intensity by using a scaling system via questionnaire; Behavioral: Side effect; investigate the presence of any side effect

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Questionnaire on postoperative pain treatment	first postoperative day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire on patients' perception of pain treatment outcome	questions related to worst pain since surgery, least pain since surgery, time in pain, interference of pain with activities, affect of pain on mood and emotions, pain therapy side effects, pain relief, wish for more treatment, information on treatment, participation in decisions, satisfaction, non-medical treatment methods and pre-hospital existence of pain.	first postoperative day

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Study Director: Winfried Meissner, Jena University Hospital; Principal Investigator: Chi Wai Cheung, MD, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: January 14, 2019
• First Submitted That Met QC Criteria: January 16, 2019
• First Posted (Actual): January 17, 2019

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: UW 18-660

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No