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RECRUITING
NCT07846878

Prospective External Validation of an Early Prediction Model for Adverse Postoperative Pain Trajectories After Orthopedic Surgery

Sponsor: First Affiliated Hospital of Chongqing Medical University

View on ClinicalTrials.gov

Summary

This prospective observational study will externally validate a previously developed and locked prediction model for identifying adult patients at risk of adverse postoperative pain trajectories after elective orthopedic surgery. Approximately 400 patients will be consecutively recruited at the First Affiliated Hospital of Chongqing Medical University. Postoperative pain will be assessed during the first 48 hours after surgery using the 0-10 Numeric Rating Scale. Pain scores will be organized into eight consecutive 6-hour time windows to determine each participant's postoperative pain trajectory according to prespecified rules. Clinical information available at the predefined prediction time point will be entered into the locked prediction model to calculate each participant's predicted probability of an adverse pain trajectory. The study will evaluate the model's discrimination, calibration, overall prediction performance, and potential clinical utility. The model will not be modified or retrained using data from this validation cohort. Individual prediction results will not be provided to patients or treating clinicians and will not be used to guide treatment during the study.

Official title: Single-Center Prospective External Validation Study of an Early Prediction Model for Adverse Postoperative Pain Trajectories After Orthopedic Surgery

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

OBSERVATIONAL

Enrollment

400

Start Date

2026-10-07

Completion Date

2027-12

Last Updated

2026-10-15

Healthy Volunteers

No

Interventions

PROCEDURE

Elective Orthopedic Surgery

Participants will undergo elective orthopedic surgery as part of routine clinical care. The surgical procedure, anesthetic management, postoperative analgesia, nursing care, and rehabilitation plan will be determined by the treating clinical team according to standard practice. The study investigators will not assign, modify, or influence these treatments. The study will prospectively collect prespecified perioperative variables and postoperative pain assessments for external validation of a locked prediction model.

Locations (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China