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Completed

NCT Number: NCT04866147

Prediction of Chronic Postsurgical Pain in Adults

This research will be a prospective single-centre observational cohort study in Denmark spanning approximately one year. The objective of this study is to develop a clinically applicable and generalizable prediction model for postsurgical pain in adults.

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Key information

Conditions

Chronic Postsurgical Pain Acute 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

Aarhus University Hospital, Aarhus N, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Consenting Danish-speaking adults aged 18 years and older
  • Patients who undergo common inpatient or outpatient surgical procedures

Exclusion criteria

  • Patients with cognitive impairment
  • Patients who refuse or unable to provide informed consent
  • Patients who undergo re-operation within 3 months of their initial surgery

Treatment and study plan

Cardiothoracic surgery

Procedure

Cardiac & large intrathoracic vessels, respiratory, thoracic, mediastinal & diaphragmatic procedures

Breast surgery

Procedure

Breast resections & mastectomies

Gastrointestinal surgery

Procedure

Digestive & spleen

Genitourinary surgery

Procedure

Urinary tract, genital & retroperitoneal tissue

orthopaedic surgery

Procedure

Back & neck, shoulder & upper arm, hip & thigh, knees & lower leg

Primary outcomes

  1. 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 using 11-point numeric rating scale (NRS; 0-10) where 0=no pain and 10=worst pain imaginable and/or average pain interference 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. Acute post surgical pain

    Time frame: First 3 hours after surgery

    Acute post surgical pain intensity in the first 3 hours after surgery measured as pain at rest using 11-point numeric rating scale (NRS; 0-10) where 0=no pain and 10=worst pain imaginable.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Prediction Model Development for Chronic Postsurgical Pain in Adults

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 29, 2021
Registry last updated
Oct 11, 2023

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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