Prediction of Chronic Postsurgical Pain in Adults

October 10, 2023 updated by: University of Aarhus

Prediction Model Development for 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1522

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Lone Nikolajsen, DMSc
  • Phone Number: +45 78 46 43 17
  • Email: loneniko@rm.dk

Study Contact Backup

  • Name: Nicholas Papadomanolakis-Pakis, MSc
  • Phone Number: +45 60 13 66 81
  • Email: nicpap@rm.dk

Study Locations

  • Denmark
      • Aarhus N, Denmark, 8200
        • Aarhus University Hospital
      • Silkeborg, Denmark
        • Silkeborg Regional Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients who undergo surgery meeting inclusion and exclusion criteria

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgery patients
Patients who undergo various common surgical procedures
Procedure: Cardiothoracic surgery
Cardiac & large intrathoracic vessels, respiratory, thoracic, mediastinal & diaphragmatic procedures
Procedure: Breast surgery
Breast resections & mastectomies
Procedure: Gastrointestinal surgery
Digestive & spleen
Procedure: Genitourinary surgery
Urinary tract, genital & retroperitoneal tissue
Procedure: Orthopaedic surgery
Back & neck, shoulder & upper arm, hip & thigh, knees & lower leg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
First 3 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Lone Nikolajsen, DMSc, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2021

Primary Completion (Actual)

May 15, 2023

Study Completion (Actual)

August 15, 2023

Study Registration Dates

First Submitted

April 26, 2021

First Submitted That Met QC Criteria

April 26, 2021

First Posted (Actual)

April 29, 2021

Study Record Updates

Last Update Posted (Actual)

October 11, 2023

Last Update Submitted That Met QC Criteria

October 10, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPSP001122

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Post Operative Pain

Clinical Trials on Cardiothoracic surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe