Clinical Prediction of Post-surgical Pain

NCT06661642 | Recruiting

• 1 other identifier: 23956082
• Study Type: observational
• Target: 748
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Postoperative Pain; Chronic Post Operative Pain

Keywords

Acute postoperative pain; Chronic postoperative pain; Prediction; Risk tool

Outcome Measures

Primary Outcomes (2)

• Moderate-to-severe acute post-surgical pain

  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.

  First 3 postoperative hours or until discharge from the PACU

• Chronic post-surgical pain

  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.

  3 months post-surgery

Secondary Outcomes (1)

• Severe acute post-surgical pain

  First 3 postoperative hours or until discharge from the PACU

Study Arms (1)

Surgery patients

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective or sub-acute surgery meeting inclusion and exclusion criteria, including thoracic, cardiac, abdominal, vascular, plastic, neurosurgery and orthopaedic surgery.

You may qualify if:

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

You may not qualify if:

• Cognitive impairment not allowing for informed consent

Sponsors & Collaborators

• Aarhus University Hospital: lead
• Aalborg University Hospital: collaborator
• University Hospital Bispebjerg and Frederiksberg: collaborator

Study Sites (2)

Aalborg University Hospital

Aalborg, 9000, Denmark

RECRUITING

Bispebjerg and Frederiksberg Hospital

Copenhagen, 2400, Denmark

COMPLETED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Lone Nikolajsen

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lone Nikolajsen

CONTACT

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

Camilla Gaarsdal Uhrbrand

CONTACT

+45 2395 6082; Camgaa@rm.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD-fellow

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 28, 2024
• Study Start: August 26, 2024
• Primary Completion: February 28, 2025
• Study Completion: August 31, 2025
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)