Clinical Prediction of Post-surgical Pain

Clinical Prediction of Post-surgical Pain: External Validation

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Postoperative Pain; Chronic Post Operative Pain

Detailed Description

Based on sample size calculations for prediction model validation, a total of 482 patients are required validation of the acute post-surgical pain model and 748 (575 + 30% for loss to follow-up) patients are required for validation of the chronic post-surgical pain model. Therefore, we will aim to recruit 748 patients in total.

• Study Type: Observational
• Enrollment (Estimated): 748

Contacts and Locations

• Study Contact: Name: Lone Nikolajsen; Phone Number: +45 7846 4317; Email: Lone.nikolajsen@clin.au.dk
• Study Contact Backup: Name: Camilla Gaarsdal Uhrbrand; Phone Number: +45 2395 6082; Email: Camgaa@rm.dk

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Recruiting
    • Aalborg University Hospital
    • Contact: Jannie Bisgaard Stæhr; Phone Number: +45 97660578; Email: j.staehr@rn.dk
  • Copenhagen, Denmark, 2400
    • Completed
    • Bispebjerg and Frederiksberg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective or sub-acute surgery meeting inclusion and exclusion criteria, including thoracic, cardiac, abdominal, vascular, plastic, neurosurgery and orthopaedic surgery.

Description

Inclusion Criteria:

All patients ≥ 18 years undergoing elective or sub-acute surgery

Exclusion Criteria:

Cognitive impairment not allowing for informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Surgery patients; Patients undergoing various elective and sub-acute surgical procedures including thoracic, cardiac, abdominal, vascular, plastic, spinal neurosurgery, and orthopaedic procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	First 3 postoperative hours or until discharge from the PACU
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.	3 months post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	First 3 postoperative hours or until discharge from the PACU

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Collaborators: University Hospital Bispebjerg and Frederiksberg; Aalborg University Hospital
• Investigators: Principal Investigator: Lone Nikolajsen, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2024
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: October 25, 2024
• First Submitted That Met QC Criteria: October 25, 2024
• First Posted (Actual): October 28, 2024

Study Record Updates

• Last Update Posted (Actual): October 28, 2024
• Last Update Submitted That Met QC Criteria: October 25, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Acute postoperative pain; Chronic postoperative pain; Prediction; Risk tool
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative
• Other Study ID Numbers: 23956082

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No