Prediction of Chronic Postsurgical Pain in Adults
Prediction Model Development for Chronic Postsurgical Pain in Adults
1 other identifier
observational
1,522
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2021
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2021
CompletedFirst Posted
Study publicly available on registry
April 29, 2021
CompletedStudy Start
First participant enrolled
May 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2023
CompletedOctober 11, 2023
October 1, 2023
2 years
April 26, 2021
October 10, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
3 months post surgery
Secondary Outcomes (1)
Acute post surgical pain
First 3 hours after surgery
Study Arms (1)
Surgery patients
Patients who undergo various common surgical procedures
Interventions
Cardiac \& large intrathoracic vessels, respiratory, thoracic, mediastinal \& diaphragmatic procedures
Back \& neck, shoulder \& upper arm, hip \& thigh, knees \& lower leg
Eligibility Criteria
Adult patients who undergo surgery meeting inclusion and exclusion criteria
You may qualify if:
- Consenting Danish-speaking adults aged 18 years and older
- Patients who undergo common inpatient or outpatient surgical procedures
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Aarhus University Hospital
Aarhus N, 8200, Denmark
Silkeborg Regional Hospital
Silkeborg, Denmark
Related Publications (1)
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.
PMID: 39297720DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lone Nikolajsen, DMSc
Aarhus University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2021
First Posted
April 29, 2021
Study Start
May 25, 2021
Primary Completion
May 15, 2023
Study Completion
August 15, 2023
Last Updated
October 11, 2023
Record last verified: 2023-10