Chronic Postsurgical PainNCT04866147
Prediction of Chronic Postsurgical Pain in Adults
An observational study of Chronic Postsurgical Pain and Acute Post Operative Pain, run by University of Aarhus at 2 sites in Denmark.
Trial summary
This research will be a prospective single-centre observational cohort study in Denmark spanning approximately one year. The objective of this study is to develop a clinically applicable and generalizable prediction model for postsurgical pain in adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Postsurgical Pain, Acute Post Operative Pain
- What is being tested?
- Cardiothoracic surgery, Breast surgery and Gastrointestinal surgery
- Type of treatment
- Surgery or procedure
- How many people
- 1,522 participants
- Where
- 2 sitesDenmark
- Study dates
- 25 May 2021to 15 Aug 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who undergo surgery meeting inclusion and exclusion criteria
Who may be able to join
- Consenting Danish-speaking adults aged 18 years and older
- Patients who undergo common inpatient or outpatient surgical procedures
Who cannot join
- Patients with cognitive impairment
- Patients who refuse or unable to provide informed consent
- Patients who undergo re-operation within 3 months of their initial surgery
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Aarhus University Hospital
Aarhus N, 8200
Silkeborg Regional Hospital
Silkeborg
About this study
Official title: Prediction Model Development for Chronic Postsurgical Pain in Adults
This research will be a prospective single-centre observational cohort study in Denmark spanning approximately one year. The objective of this study is to develop a clinically applicable and generalizable prediction model for postsurgical pain in adults.
- Being tested
- Cardiothoracic surgery, Breast surgery, Gastrointestinal surgery, Genitourinary surgery, Orthopaedic surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiothoracic surgeryProcedure or surgery
Cardiac \& large intrathoracic vessels, respiratory, thoracic, mediastinal \& diaphragmatic procedures
Breast surgeryProcedure or surgery
Breast resections \& mastectomies
Gastrointestinal surgeryProcedure or surgery
Digestive \& spleen
Genitourinary surgeryProcedure or surgery
Urinary tract, genital \& retroperitoneal tissue
Orthopaedic surgeryProcedure or surgery
Back \& neck, shoulder \& upper arm, hip \& thigh, knees \& lower leg
| Study group | Role | What they receive |
|---|---|---|
| Surgery patients | Patients who undergo various common surgical procedures Receives: Procedure: Cardiothoracic surgery; Procedure: Breast surgery; Procedure: Gastrointestinal surgery; Procedure: Genitourinary surgery; Procedure: Orthopaedic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic post surgical pain
Pain related to the surgical procedure measured as average pain intensity on rest or movement using 11-point numeric rating scale (NRS; 0-10) where 0=no pain and 10=worst pain imaginable and/or average pain interference using 11-point NRS among any one of seven short-form Brief Pain Inventory items (general activity, mood, walking ability, normal work (including housework), relations with other people, sleep, enjoyment of life) in the past one week, where 0=pain does not interfere and 10=pain completely interferes.
Measured: 3 months post surgery
Secondary outcomes (1)
Acute post surgical pain
Acute post surgical pain intensity in the first 3 hours after surgery measured as pain at rest using 11-point numeric rating scale (NRS; 0-10) where 0=no pain and 10=worst pain imaginable.
Measured: First 3 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start25 May 2021
- Primary completion15 May 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Postsurgical PainStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- 1,522 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lone Nikolajsen, DMSc, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04866147
- Sponsor's protocol ID
- CPSP001122
- Status last verified
- Oct 2023
- First submitted
- 26 Apr 2021
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Papadomanolakis-Pakis N, Haroutounian S, Sorensen JK, Runge C, Brix LD, Christiansen CF, Nikolajsen L. Development and internal validation of a clinical risk tool to predict chronic postsurgical pain in adults: a prospective multicentre cohort study. Pain. 2025 Mar 1;166(3):667-679. doi: 10.1097/j.pain.0000000000003405. Epub 2024 Sep 18.
PubMed 39297720
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction Model Development for Chronic Postsurgical Pain in Adults
- ClinicalTrials.gov ID
- NCT04866147
- Acronym / sponsor ID
- CPSP001122
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,522 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 25 May 2021 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 29 Apr 2021 (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.
This research will be a prospective single-centre observational cohort study in Denmark spanning approximately one year. The objective of this study is to develop a clinically applicable and generalizable prediction model for postsurgical pain in adults.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery patients | – | Procedure: Cardiothoracic surgery, Procedure: Breast surgery, Procedure: Gastrointestinal surgery, Procedure: Genitourinary surgery, Procedure: Orthopaedic surgeryPatients who undergo various common surgical procedures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who undergo surgery meeting inclusion and exclusion criteria
Key inclusion criteria (2 listed)
- Consenting Danish-speaking adults aged 18 years and older
- Patients who undergo common inpatient or outpatient surgical procedures
Key exclusion criteria (3 listed)
- Patients with cognitive impairment
- Patients who refuse or unable to provide informed consent
- Patients who undergo re-operation within 3 months of their initial surgery
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 |
|---|---|---|
| Cardiothoracic surgeryCardiac \& large intrathoracic vessels, respiratory, thoracic, mediastinal \& diaphragmatic procedures | Procedure or surgery | Surgery patients |
| Breast surgeryBreast resections \& mastectomies | Procedure or surgery | Surgery patients |
| Gastrointestinal surgeryDigestive \& spleen | Procedure or surgery | Surgery patients |
| Genitourinary surgeryUrinary tract, genital \& retroperitoneal tissue | Procedure or surgery | Surgery patients |
| Orthopaedic surgeryBack \& neck, shoulder \& upper arm, hip \& thigh, knees \& lower leg | Procedure or surgery | Surgery patients |
Primary outcome
Chronic post surgical pain
Time frame: 3 months post surgery
Pain related to the surgical procedure measured as average pain intensity on rest or movement using 11-point numeric rating scale (NRS; 0-10) where 0=no pain and 10=worst pain imaginable and/or average pain interference using 11-point NRS among any one of seven short-form Brief Pain Inventory items (general activity, mood, walking ability, normal work (including housework), relations with other people, sleep, enjoyment of life) in the past one week, where 0=pain does not interfere and 10=pain completely interferes.
1 secondary outcome
Acute post surgical pain
Time frame: First 3 hours after surgery
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 11 Oct 2023.
- Derived from this study: PubMed 39297720Papadomanolakis-Pakis N, Haroutounian S, Sorensen JK, Runge C, Brix LD, Christiansen CF, Nikolajsen L. Development and internal validation of a clinical risk tool to predict chronic postsurgical pain in adults: a prospective multicentre cohort study. Pain. 2025 Mar 1;166(3):667-679. doi: 10.1097/j.pain.0000000000003405. Epub 2024 Sep 18.
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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.
Lone Nikolajsen, DMSc principal investigator
Aarhus University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Postsurgical Pain and Acute Post Operative Pain, run by University of Aarhus at 2 sites in Denmark.
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 2 inclusion and 3 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 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Chronic post surgical pain (time frame: 3 months post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04866147, which also lists 1 linked publication.
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 11 Oct 2023.