Actively Recruiting
Clinical Prediction of Post-surgical Pain: External Validation
Led by Aarhus University Hospital · Updated on 2024-10-28
748
Participants Needed
2
Research Sites
26 weeks
Total Duration
On this page
Sponsors
A
Aarhus University Hospital
Lead Sponsor
A
Aalborg University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to externally validate two clinical prediction models for moderate-to-severe acute post-surgical pain and chronic post-surgical pain. It is a multi-centre, prospective cohort study conducted in Denmark involving adult patients undergoing various elective or sub-acute surgical procedures. The study is designed to help better predict pain levels in patients after surgery. The study will recruit a total of 748 patients to meet sample size requirements for validating both prediction models. Participants include patients having thoracic, cardiac, abdominal, vascular, plastic, spinal neurosurgery, and orthopedic surgeries. No interventions or treatments are assigned as this is an observational study. During the study, researchers will assess moderate-to-severe acute post-surgical pain within the first 3 postoperative hours or until discharge from the Post Anesthesia Care Unit (PACU). They will also evaluate chronic post-surgical pain at 3 months after surgery. Additional assessments include severe acute post-surgical pain during the initial 3 hours or until PACU discharge. The study involves monitoring pain outcomes without altering usual care.
CONDITIONS
Brief Title
Clinical Prediction of Post-surgical Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older
- Undergoing elective or sub-acute surgical procedures
You will not qualify if you...
- Cognitive impairment that prevents informed consent
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - First 3 postoperative hours or until discharge from the PACU
Participants undergo elective or sub-acute surgical procedures and are monitored for pain during the first 3 postoperative hours or until discharge from the post-anesthesia care unit (PACU).
1 surgical and immediate post-operative monitoring period
Duration - 3 months post-surgery
Participants are followed up to assess chronic post-surgical pain outcomes 3 months after surgery.
1 follow-up visit at 3 months post-surgery
Trial Site Locations
Total: 2 locations
1
Aalborg University Hospital
Aalborg, Denmark, 9000
Actively Recruiting
2
Bispebjerg and Frederiksberg Hospital
Copenhagen, Denmark, 2400
Completed
Research Team
L
Lone Nikolajsen
C
Camilla Gaarsdal Uhrbrand
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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