Prediction of Chronic Postsurgical Pain in Adults

• Sponsor: University of Aarhus (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04866147
• Collaborator: (none)
• Enrollment: 1,526
• Locations: 2
• Anticipated Duration (Months): 17.2
• Patients Per Site: 763
• Patients Per Site Per Month: 44.3

Study Details

Study Description

Brief 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 CPSP in adults.

Condition or Disease	Intervention/Treatment	Phase
Chronic Postsurgical Pain	Procedure: Cardiothoracic surgery; Procedure: Breast surgery; Procedure: Gastrointestinal surgery; Procedure: Genitourinary surgery; Procedure: Obstetric surgery; Procedure: Orthopaedic surgery

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1526 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prediction Model Development for Chronic Postsurgical Pain in Adults
• Actual Study Start Date: May 25, 2021
• Anticipated Primary Completion Date: Oct 31, 2022
• Anticipated Study Completion Date: Oct 31, 2022

Arms and Interventions

Arm

Intervention/Treatment

Chronic postsurgical pain 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: Obstetric surgery; Caesarian sections; Procedure: Orthopaedic surgery; Back & neck, shoulder & upper arm, hip & thigh, knees & lower leg

Outcome Measures

Primary Outcome Measures

1. Chronic post surgical pain [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aarhus University Hospital	Aarhus N		Denmark	8200
2	Silkeborg Regional Hospital	Silkeborg		Denmark

Sponsors and Collaborators

• University of Aarhus

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Aarhus
• ClinicalTrials.gov Identifier: NCT04866147
• Other Study ID Numbers: CPSP001122
• First Posted: Apr 29, 2021
• Last Update Posted: Mar 9, 2022
• Last Verified: Apr 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pain, Postoperative

Study Results

No Results Posted as of Mar 9, 2022