External validation of an early predictor for adverse postoperative pain trajectories after orthopedic surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, prospective observational study that externally validates an existing early prediction model for adverse postoperative pain trajectories in adults undergoing elective orthopedic surgery. Data will be collected from routine perioperative care and electronic records to compute predicted probabilities of adverse pain trajectories during the first 48 hours post-surgery. Pain will be measured every 6 hours using a 0-10 scale, and the model’s discrimination, calibration, and clinical utility will be assessed using prespecified rules. No interventions or changes to standard care will be made based on the predictions, and researchers will lock the model’s specifications prior to enrolling participants. About 400 consecutive patients at the First Affiliated Hospital of Chongqing Medical University are planned for inclusion.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.
* Able and willing to provide written informed consent before any study-specific data collection.

Exclusion Criteria:

* 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 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.
* Lacks full capacity to provide valid informed consent.
* Concurrent participation in another clinical study that may affect pain assessment, analgesic treatment, or study outcomes.
* Expected discharge or transfer within 48 hours after surgery, or inability to complete the main study observation because of clinical circumstances.
* Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study.

Where it's running

• The First Affiliated Hospital of Chongqing Medical University
  Chongqing, China Recruiting

Study contacts

• Study coordinator: Lihua Peng
• Email: plhcqmu@163.com
• Phone: +86 15823443968

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.