Clinical Prediction of Post-surgical Pain

Recruiting

• Conditions: Acute Postoperative Pain; Chronic Post Operative Pain

• Registration Number: NCT06661642
• Lead Sponsor: Aarhus University Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2024-08-26
• Status Verified: 2024-10
• Study First Submitted: 2024-10-25
• Study First Submitted QC: 2024-10-25
• Last Update Submitted: 2024-10-25
• Study First Posted: 2024-10-28
• Last Update Posted: 2024-10-28
• Primary Completion: 2025-02-28
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 748

Inclusion Criteria

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

Exclusion Criteria

Cognitive impairment not allowing for informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Moderate-to-severe acute post-surgical pain	First 3 postoperative hours or until discharge from the PACU	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.
Chronic post-surgical pain	3 months post-surgery	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.

Secondary Outcome Measures

Name	Time	Method
Severe acute post-surgical pain	First 3 postoperative hours or until discharge from the PACU	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.

Trial Locations

Locations (2)

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Bispebjerg and Frederiksberg Hospital; 🇩🇰 Copenhagen, Denmark