Clinical Prediction of Post-surgical Pain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAarhus University Hospital
About this trial
This study aims to externally validate two clinical prediction models for moderate-to-severe acute post-surgical pain and chronic post-surgical pain. This multi-centre, prospective cohort study will be conducted in Denmark and will include adult patients undergoing various types of elective or sub-acute surgical procedures.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Patients undergoing elective or sub-acute surgery meeting inclusion and exclusion criteria, including thoracic, cardiac, abdominal, vascular, plastic, neurosurgery and orthopaedic surgery.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
748 Participants
are grouped into 1 trial groupGroup A: Surgery patients
Trial outcomes
Primary outcomes
1
Moderate-to-severe acute post-surgical pain
Worst pain intensity score at rest ≥ 4 on an 11-point numeric rating scale (NRS; 0-10) in the post-anaesthesia care unit (PACU) following surgery, where 0=no pain and 10=worst pain imaginable.
Time frame
First 3 postoperative hours or until discharge from the PACU2
Chronic post-surgical pain
Pain related to the surgical procedure measured as average pain intensity on rest or movement ≥ 3 in the past one week using an 11-point numeric rating scale (NRS; 0-10) where 0=no pain and 10=worst pain imaginable and average pain interference ≥ 3 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.
Time frame
3 months post-surgerySecondary outcomes
1
Severe acute post-surgical pain
Worst pain intensity score at rest ≥ 7 on an 11-point numeric rating scale (NRS; 0-10) in the post-anaesthesia care unit (PACU) following surgery, where 0=no pain and 10=worst pain imaginable.
Time frame
First 3 postoperative hours or until discharge from the PACUSponsors and contacts
Click on the lead sponsor to view all of their trials.
Aarhus University Hospital
Lead sponsor
Aalborg University Hospital
Collaborator
University Hospital Bispebjerg and Frederiksberg
Collaborator
Source ClinicalTrials.gov