Prospective Observational Study on Postoperative Pain and Side Effect

Postoperative Pain Clinical Trial

— Pain Out  

Official title:

Improvement in Postoperative Pain Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03808220
• Other study ID #: UW 18-660
• Status: Completed
• Start date: January 20, 2019
• Est. completion date: July 26, 2021

Study information

• Verified date: May 2024
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2197
• Est. completion date: July 26, 2021
• Est. primary completion date: July 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Behavioral:
• postoperative pain intensity
estimate the postoperative pain intensity by using a scaling system via questionnaire
• preoperative pain frequency
estimate the preoperative pain intensity by using a scaling system via questionnaire
• Side effect
investigate the presence of any side effect

Locations

Country	Name	City	State
Hong Kong	The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Questionnaire on postoperative pain treatment		first postoperative day
Secondary	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