Postoperative PainPain OutNCT03808220
Prospective Observational Study on Postoperative Pain and Side Effect
An observational study of Postoperative Pain, run by The University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- postoperative pain intensity, preoperative pain frequency and Side effect
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,197 participants
- Where
- 1 siteHong Kong
- Study dates
- 20 Jan 2019to 26 Jul 2021
- How long will I take part?
- 12 Months
- 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 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: adult post-surgical patients in hospitals on post-op day 1
Who may be able to join
- >= 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
Who cannot join
- patient cannot communicate
- patient is cognitively impaired
- patient is asleep
- patient is too ill
- patient does not want to fill in the questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- postoperative pain intensity, preoperative pain frequency, Side effect
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
postoperative pain intensityBehavioural
estimate the postoperative pain intensity by using a scaling system via questionnaire
preoperative pain frequencyBehavioural
estimate the preoperative pain intensity by using a scaling system via questionnaire
Side effectBehavioural
investigate the presence of any side effect
| Study group | Role | What they receive |
|---|---|---|
| post-surgical patients | post-surgical patients > 18 years Receives: Behavioral: postoperative pain intensity; Behavioral: preoperative pain frequency; Behavioral: Side effect | |
| pediatric patients post-op day 1 | pediatric patients > 4 years on post-op day 1 (sub-project QUIPSI - PAIN OUTinfant) Receives: Behavioral: postoperative pain intensity; Behavioral: preoperative pain frequency; Behavioral: Side effect |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire on postoperative pain treatment
Measured: first postoperative day
Secondary outcomes (1)
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.
Measured: first postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start20 Jan 2019
- Primary completion26 Jul 2021
- Study completion26 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 2,197 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Chi-Wai Cheung, The University of Hong Kong
- Investigators
- Winfried Meissner, Study director, Jena University HospitalChi Wai Cheung, MD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03808220
- Sponsor's protocol ID
- UW 18-660
- Acronym
- Pain Out
- Status last verified
- May 2024
- First submitted
- 14 Jan 2019
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement in Postoperative Pain Outcome
- ClinicalTrials.gov ID
- NCT03808220
- Acronym / sponsor ID
- Pain Out / UW 18-660
- Conditions
- Postoperative Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,197 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 20 Jan 2019 (actual)
- Primary completion
- 26 Jul 2021 (actual)
- Study completion
- 26 Jul 2021 (actual)
- First posted
- 17 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PAIN OUT is a multi-national, non-interventional registry and benchmark project, assessing and analysing clinical and patient-reported outcome data of postoperative pain.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| post-surgical patients | – | Behavioral: postoperative pain intensity, Behavioral: preoperative pain frequency, Behavioral: Side effectpost-surgical patients > 18 years |
| pediatric patients post-op day 1 | – | Behavioral: postoperative pain intensity, Behavioral: preoperative pain frequency, Behavioral: Side effectpediatric patients > 4 years on post-op day 1 (sub-project QUIPSI - PAIN OUTinfant) |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- adult post-surgical patients in hospitals on post-op day 1
Key inclusion criteria (4 listed)
- >= 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
Key exclusion criteria (5 listed)
- patient cannot communicate
- patient is cognitively impaired
- patient is asleep
- patient is too ill
- patient does not want to fill in the questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| postoperative pain intensityestimate the postoperative pain intensity by using a scaling system via questionnaire | Behavioural | pediatric patients post-op day 1, post-surgical patients |
| preoperative pain frequencyestimate the preoperative pain intensity by using a scaling system via questionnaire | Behavioural | pediatric patients post-op day 1, post-surgical patients |
| Side effectinvestigate the presence of any side effect | Behavioural | pediatric patients post-op day 1, post-surgical patients |
Primary outcome
Questionnaire on postoperative pain treatment
Time frame: first postoperative day
1 secondary outcome
Questionnaire on patients' perception of pain treatment outcome
Time frame: first postoperative day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
Related trials for Postoperative Pain
Recruiting
Postoperative Delirium and Analgesia in Elderly Patients
Postoperative Delirium, Postoperative Pain, Acute
Not yet recruiting
Effect of Stress Ball Use on Perioperative Anxiety and Postoperative Pain in Parturients Undergoing Cesarean Section
Postoperative Pain
Not yet recruiting
Effect of Sacral Erector Spinae Plane Block on Quality of Recovery After Cesarean Delivery: A Prospective Randomized Controlled Trial
Pain, Postoperative Pain
Not yet recruiting
VibraCool Device to Reduce Pain and Opioid Use After Anterior Cruciate Ligament Reconstruction (ACLR)
ACL, Opioid Use
RecruitingPhase 4
Post-Operative Pain Relief: Zynrelef or Periarticular Injections in RATKA
Periarticular Block, Osteoarthritis (OA)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Winfried Meissner study director
Jena University Hospital
Chi Wai Cheung, MD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, run by The University of Hong Kong at 1 site in Hong Kong.
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 4 inclusion and 5 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 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. 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?
Questionnaire on postoperative pain treatment (time frame: first postoperative day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2024.