Effect of Preoperative Sleep Disturbance on Postoperative Pain and Recovery

NCT06815744 | Completed

• 1 other identifier: 2023-044-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Total Knee Arthroplasty (TKA)

Keywords

total knee arthroplasty; sleep quality; postoperative pain; quality of recovery; brain-derived neurotrophic factor; cannabinoid receptor type 1

Outcome Measures

Primary Outcomes (1)

• postoperative pain score

  The numerical rating scale (NRS) was used to evaluate the level of postoperative pain in patients. NRS scores were recorded at 2h, 6h, 12h, 24h, and 48h postoperatively, and the incidence of moderate to severe pain at corresponding time points was calculated. On this scale, 0 represents no pain, while 10 represents the worst imaginable pain. Based on the NRS scores, patients were classified into three pain categories: no pain (0), mild pain (1-3/10), and moderate to severe pain (≥4/10)

  Day 0，Day 1，Day 2

Secondary Outcomes (3)

• consumption of hydromorphone (HM)

  D1

• the number of rescue analgesia

  Day 1

• QoR-15 score

  Day 1

Other Outcomes (1)

• Serum BDNF and CB1R concentrations

  pre-anesthetic

Study Arms (2)

the normal sleep group

The Pittsburgh Sleep Quality Index Questionnaire (PSQI) ≤ 5

the poor sleep group (PSQI > 5)

The Pittsburgh Sleep Quality Index Questionnaire (PSQI) \> 5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who were scheduled to undergo primary unilateral TKA at Gansu Provincial Hospital of TCM from November 2023 to January 2024 were selected as the study subjects.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gansu Provincial Hospital: lead

Study Sites (1)

Gansu provincial hospital of TCM

Lanzhou, Gansu, 730050, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Before anesthesia, 3 ml of venous blood was collected from the non-infusion side of the patient (on an empty stomach). The whole blood was collected into a blood collection tube containing EDTA sodium salt. After standing at room temperature for 30 minutes, the blood was centrifuged at 3000 rpm for 10 minutes. The supernatant was then placed in a cryopreservation box and stored at -80℃ until use.

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Pain, Postoperative

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Jianjun Xue

  Gansu provincial hospital of TCM

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident physician

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 7, 2025
• Study Start: November 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: February 7, 2025

Record last verified: 2025-02

Locations

CN (1)