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NCT Number: NCT06661642

Clinical Prediction of Post-surgical Pain

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.

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Key information

Conditions

Acute Postoperative Pain Chronic Post Operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aalborg University Hospital, Aalborg, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Cognitive impairment not allowing for informed consent

Treatment and study plan

Primary outcomes

  1. Moderate-to-severe acute post-surgical pain

    Time frame: 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.

  2. Chronic post-surgical pain

    Time frame: 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 outcomes

  1. Severe acute post-surgical pain

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Camilla Gaarsdal Uhrbrand

CONTACT

[email protected]

+45 2395 6082

Lone Nikolajsen

CONTACT

[email protected]

+45 7846 4317

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • Aalborg University Hospital
  • University Hospital Bispebjerg and Frederiksberg

Registry information

Official study title

Clinical Prediction of Post-surgical Pain: External Validation

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 28, 2024
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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