Perioperative Sleep Quality and Postoperative Pain Outcomes

Study Overview
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Brief Summary
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This is a prospective, observational cohort study that will examine how sleep quality impacts postoperative pain and opioid consumption for pediatric patients. The investigators will administer a questionnaire preoperatively to determine which patients have poor or good sleep quality. They will then compare postoperative pain and opioid use between groups for two weeks following surgery. For a secondary aim, investigators will use electronic medication vials (eCAP) to monitor participants' medication use at home and compare to self-reporting.

Official Title
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The Influence of Perioperative Sleep Quality on Postoperative Pain Outcomes in Pediatric Patients Undergoing Knee Surgery

Conditions
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Surgery, ACL Injury, Pain, Sleep

Intervention / Treatment
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* Device: eCAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: able to read, understand, and speak English are undergoing ACL repair or reconstruction have availability of a mobile device/computer to receive text messages Exclusion Criteria: < 10 or > 18 years of age have a history of sleep-disordered breathing including sleep apnea have a history of chronic pain or current opioid use have a history of developmental delay that would preclude study participation

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ACL surgery<br>Pediatric subjects undergoing surgery for ACL repair. | Device: eCAP<br>* eCap™ has the look and feel of a regular prescription bottle and records real-time adherence data, tracking each opening with the date and time.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburgh Sleep Quality Index | Pittsburgh Sleep Quality Index (PSQI) is a validated, self-report questionnaire that assesses sleep quality over a one-month period that takes five to ten minutes to complete. It offers seven component scores (e.g., subjective sleep quality, latency, duration, and efficiency) as well as a composite score that measures overall sleep quality. A total score greater than five yields a sensitivity of 89.6% and specificity of 86.5% (kappa = 0.75, p <0.001) in distinguishing good from poor sleepers. | Baseline | 
| Difference in opioid consumption between self-report and eCap | The eCAP Electronic Content Monitor (ECM) is a smart pill bottle used to monitor and improve medication adherence. When opened, an event is recorded, and the data is securely stored. The eCAP device timestamps medication usage and provides a visualization demonstrating how patients are taking medications, providing robust analytics. Subjects will also record each time they take an opioid pain medicine on a daily diary. | Days 1-14 post-op |