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Recruiting NCT06661642

Clinical Prediction of Post-surgical Pain

Observational Acute Postoperative Pain Chronic Post Operative Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Acute Postoperative Pain, Chronic Post Operative Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Clinical Prediction of Post-surgical Pain: External Validation

Overview

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.

Primary outcome measures

  • Moderate-to-severe acute post-surgical pain [Time frame: First 3 postoperative hours or until discharge from the PACU]
  • Chronic post-surgical pain [Time frame: 3 months post-surgery]
Secondary outcome measures (1)
  • Severe acute post-surgical pain [Time frame: First 3 postoperative hours or until discharge from the PACU]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

Cognitive impairment not allowing for informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Denmark · 2 centers
  • Aalborg University Hospital — Aalborg
  • Bispebjerg and Frederiksberg Hospital — Copenhagen

Identifiers

NCT: NCT06661642 · 23956082

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗