CompletedNot Applicable

Effect of Preoperative Sleep Disturbance on Postoperative Pain and Recovery

China200 participantsStarted 2023-11-01

Plain-language summary

The study subjects consisted of patients who underwent elective total knee arthroplasty (TKA) at Gansu Provincial Hospital of TCM from November 2023 to January 2024. The Pittsburgh Sleep Quality Index Questionnaire (PSQI) was used to assess the overall sleep status of patients over the past month. All patients were divided into normal sleep group (PSQI ≤ 5) and poor sleep group (PSQI score \> 5). Postoperative pain was assessed using a numeric rating scale (NRS), and hydromorphone (HM) consumption, number of rescue analgesia, and quality of recovery QoR-15 scores were recorded 24 hours after surgery. Spearman correlation analysis was used to detect the correlation between each index and preoperative PSQI score. A logistic regression model was used to analyze the relationship between PSQI score, serum BDNF and CB1R concentrations, and the occurrence of moderate to severe pain 24 hours after surgery. Generalized linear regression models combined with restricted cubic spline models were used to analyze the relationship and dose-response relationship between PSQI, BDNF, and CB1R and QoR-15 score and HM consumption at 24 hours after surgery after adjusting for confounders. Serum BDNF and CB1R mediation effects were analyzed by Process plug-in.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * aged ≥ 18 years; patients scheduled for elective unilateral TKA under spinal anesthesia; American Society of Anesthesiologists (ASA) classification I-III ; voluntary participation and signed informed consent Exclusion Criteria: * unwillingness to participate in this study; concomitant serious underlying diseases that could affect postoperative rehabilitation; revision TKA ; severe neuropsychiatric disorders, especially depression, which could affect sleep quality.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

postoperative pain score

Timeframe: Day 0，Day 1，Day 2

Trial details

NCT IDNCT06815744

SponsorGansu Provincial Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-01-31

View on ClinicalTrials.gov More Total Knee Arthroplasty (TKA) trials