About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 to 90 years, regardless of sex.
Scheduled to undergo an eligible elective orthopedic surgical procedure at the First Affiliated Hospital of Chongqing Medical University.
Expected to remain hospitalized for at least 48 hours after surgery.
Conscious before surgery, with sufficient understanding and communication ability to understand and complete the 0-10 Numeric Rating Scale for pain.
Disqualifiers
Younger than 18 years or older than 90 years.
Emergency surgery, unplanned surgery, or a surgical procedure outside the prespecified orthopedic surgical scope of the study.
Unable to reliably understand the study or complete the Numeric Rating (4)Scale because of impaired consciousness, severe cognitive impairment, psychiatric disorder, persistent deep sedation, mechanical ventilation, severe hearing impairment, language or communication difficulties, or similar conditions.
Trial population
Adult patients undergoing elective orthopedic surgery at the First Affiliated Hospital of Chongqing Medical University who are expected to remain hospitalized for at least 48 hours after surgery. Eligible procedures include major categories of elective orthopedic surgery, such as spinal surgery, hip or knee arthroplasty, pelvic or extremity fracture fixation, and orthopedic corrective surgery. Participants will be prospectively and consecutively screened and enrolled according to the prespecified eligibility criteria.
Trial design
Cohort
Prospective
Treatments tested in this trial
Elective Orthopedic Surgery
Procedure/SurgeryParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
Proportion of Participants With an Adverse Postoperative Pain Trajectory
Participants will be classified as having an adverse or non-adverse postoperative pain trajectory based on pain scores collected during the first 48 hours after surgery and the prespecified, locked trajectory classification and mapping rules. The number and percentage of participants classified as having an adverse postoperative pain trajectory will be reported.
Secondary outcomes
Area Under the Receiver Operating Characteristic Curve (AUC)
The area under the receiver operating characteristic curve (AUC) will be used to assess the discrimination of the locked prediction model for distinguishing participants with and without an adverse postoperative pain trajectory. The AUC ranges from 0.5, indicating no discrimination, to 1.0, indicating perfect discrimination. The AUC and its 95% confidence interval will be reported.
Brier Score
The Brier score will be used to evaluate the overall predictive performance of the locked prediction model by comparing predicted probabilities with the observed binary adverse postoperative pain trajectory outcome. Lower values indicate better overall predictive performance. The Brier score and its 95% confidence interval will be reported.
Calibration Intercept
Calibration intercept will be used to assess systematic overestimation or underestimation of predicted risk by the locked prediction model. A value of 0 indicates ideal calibration. The calibration intercept and its 95% confidence interval will be reported.
Calibration Slope
Calibration slope will be used to assess the agreement between the spread of predicted probabilities and observed outcomes. A value of 1 indicates ideal calibration. The calibration slope and its 95% confidence interval will be reported.
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