Clinical Prediction of Post-surgical Pain

NCT ID: NCT06661642

Last Updated: 2024-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

748 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-26

Study Completion Date

2025-08-31

Brief Summary

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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

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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.

Conditions

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Acute Postoperative Pain Chronic Post Operative Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Surgery patients

Patients undergoing various elective and sub-acute surgical procedures including thoracic, cardiac, abdominal, vascular, plastic, spinal neurosurgery, and orthopaedic procedures.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

Cognitive impairment not allowing for informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aalborg University Hospital

OTHER

Sponsor Role collaborator

University Hospital Bispebjerg and Frederiksberg

OTHER

Sponsor Role collaborator

Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Camilla Gaarsdal Uhrbrand

MD, PhD-fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lone Nikolajsen

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

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Aalborg University Hospital

Aalborg, , Denmark

Site Status RECRUITING

Bispebjerg and Frederiksberg Hospital

Copenhagen, , Denmark

Site Status COMPLETED

Countries

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Denmark

Central Contacts

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Lone Nikolajsen

Role: CONTACT

+45 7846 4317

Camilla Gaarsdal Uhrbrand

Role: CONTACT

+45 2395 6082

Facility Contacts

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Jannie Bisgaard Stæhr

Role: primary

+45 97660578

Other Identifiers

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23956082

Identifier Type: -

Identifier Source: org_study_id

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