Clinical Prediction of Post-surgical Pain

Clinical Prediction of Post-surgical Pain: External Validation

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06661642

Enrollment

748

Registered

2024-10-28

Start date

2024-08-26

Completion date

2025-08-31

Last updated

2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Postoperative Pain, Chronic Post Operative Pain

Keywords

Acute postoperative pain, Chronic postoperative pain, Prediction, Risk tool

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

Cognitive impairment not allowing for informed consent

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Denmark

Contacts

Primary ContactLone Nikolajsen

Lone.nikolajsen@clin.au.dk+45 7846 4317

Backup ContactCamilla Gaarsdal Uhrbrand

Camgaa@rm.dk+45 2395 6082

Outcome results