Prediction of Chronic Postsurgical Pain in Adults

Chronic Postsurgical Pain Clinical Trial

Official title:

Prediction Model Development for Chronic Postsurgical Pain in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04866147
• Other study ID #: CPSP001122
• Status: Completed
• Start date: May 25, 2021
• Est. completion date: August 15, 2023

Study information

• Verified date: October 2023
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1522
• Est. completion date: August 15, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Postsurgical Pain
• Pain, Postoperative

Intervention

Procedure:
• Cardiothoracic surgery
Cardiac & large intrathoracic vessels, respiratory, thoracic, mediastinal & diaphragmatic procedures
• Breast surgery
Breast resections & mastectomies
• Gastrointestinal surgery
Digestive & spleen
• Genitourinary surgery
Urinary tract, genital & retroperitoneal tissue
• Orthopaedic surgery
Back & neck, shoulder & upper arm, hip & thigh, knees & lower leg

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus N
Denmark	Silkeborg Regional Hospital	Silkeborg

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic post surgical pain	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	Acute post surgical pain	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