Effect of Perioperative Sleep Quality on Chronic Post-Surgical Pain

NCT06871891 | Not Yet Recruiting DMC

• 1 other identifier: K7648
• Study Type: observational
• Target: 1,138
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective observational cohort study is to assess the impact of perioperative sleep quality on the development of chronic post-surgical pain (CPSP) in adult patients (aged 18-80 years, ASA I-III) undergoing elective video-assisted thoracic surgery (VATS), modified radical mastectomy (MRM), or coronary artery bypass grafting (CABG). The main questions it aims to answer are: Does poor perioperative sleep quality increase the risk of CPSP at 3 months post-surgery? How do subjective and objective sleep parameters (e.g., total sleep duration, deep sleep time) correlate with CPSP and recovery outcomes? Researchers will compare patients with varying perioperative sleep quality levels (assessed via the Richards-Campbell Sleep Questionnaire \[RCSQ\] and wearable device data) to evaluate differences in CPSP incidence, pain and quality of life. Participants will: Wear a Huawei wearable device to collect objective sleep data (e.g., sleep duration, deep sleep time) during hospitalization. Complete questionnaires preoperatively and postoperatively, including RCSQ, Pittsburgh Sleep Quality Index (PSQI), Hospital Anxiety and Depression Scale (HADS), and Brief Pain Inventory (BPI). Undergo follow-up assessments at 1, 3, and 6 months post-surgery to evaluate pain scores , CPSP status, and quality of life (SF-36).

Conditions

Chronic Post-Surgical Pain

Outcome Measures

Primary Outcomes (2)

• chronic post-surgical pain (CPSP): Brief Pain Inventory (BPI)

  The Brief Pain Inventory (BPI) is a widely used pain assessment tool for evaluating pain intensity and impact, suitable for chronic pain patients. It measures current, least, worst and average pain in the past 24 hours on a 0 - 10 scale (0=no pain, 10=extreme pain), and assesses pain's effect on 7 daily life aspects, scored 0 - 10 (0=no interference, 10=total interference). If a participant's BPI evaluation shows a pain condition and also meets these five criteria: (1) Pain arises or intensifies following surgery; (2) Pain persists for at least three months and impacts quality of life; (3)Pain occurs after a pain-free interval or evolves from ongoing acute postoperative pain; (4) Pain is localized to the surgical site or radiates to areas corresponding to the relevant nerve distribution; and (5) Other potential causes of pain are excluded.

  at 3 months after surgery

• Subjective sleep assessment: Richards - Campbell Sleep Questionnaire (RCSQ)

  The Richards-Campbell Sleep Questionnaire (RCSQ) is a prominent tool in sleep research and clinical practice for gauging sleep quality. It comprehensively evaluates sleep aspects from respondents' subjective views. Comprising multiple items, it covers sleep onset latency (time to fall asleep), sleep depth, sleep duration, and wake-up frequency at night. It may also involve related factors like sleep environment quality and sleep's impact on daily life. With specific questions and response options, individuals rate sleep experiences numerically or descriptively. Data from the RCSQ aids in diagnosing sleep disorders, evaluating treatment efficacy, and conducting sleep-related epidemiological studies. It is mainly intended for the assessment of short-term sleep conditions during hospitalization.

  1 day before surgery and 1st, 2nd, and 3rd days after surgery.

Secondary Outcomes (5)

• Pain assessment: Numerical rating scale (NRS)

  1st, 2nd, 3rd days after surgery and at 1 months after surgery

• chronic post-surgical pain (CPSP) : Brief Pain Inventory (BPI)

  at 6 months after surgery

• Quality of life assessment: Short Form-36 Health Survey Questionnaire (SF-36)

  1, 3, 6 months after surgery

• Quality of recovery assessment: Quality of Recovery-15 (QoR-15) assessment scale

  1st and 3rd days after surgery

• Subjective sleep assessment: Pittsburgh Sleep Quality Index (PSQI)

  1, 3, and 6 months after surgery.

Other Outcomes (1)

• Objective sleep assessment: Total sleep duration, wake - up time during sleep, and deep sleep time.

  Preoperative day 1 (the night before surgery), the night of surgery (postoperative day 0), and postoperative days 1, 2, and 3

Study Arms (1)

SLEEP-CPSP Cohort

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from Peking Union Medical College Hospital, Fuwai Hospital, and Cancer Hospital to reflect diverse clinical practices.

You may qualify if:

• Aged 18-80 years.
• Scheduled for elective video-assisted thoracic surgery (VATS).
• Scheduled for elective modified radical mastectomy (MRM).
• Scheduled for elective coronary artery bypass grafting (CABG).
• American Society of Anesthesiologists (ASA) physical status classification I-III.
• Willing to sign the informed consent form, participate in the study, and complete all follow-up assessments.

You may not qualify if:

• History of surgery within the past 3 months.
• Chronic use of opioids or sedatives (defined as use for 3 months or longer).
• Expected completion time of surgery after 16:00 on the day of operation.
• Planned transfer to the intensive care unit (ICU) postoperatively.
• Anticipated hospital stay \<24 hours.
• Contraindications to wearable device use (e.g., infection at the wrist site, allergy to the wristband material).

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator
• National Cancer Center/National Cancer Clinical Medical Research Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College: collaborator

Study Sites (1)

Department of Anesthesiology, Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Lu Che

CONTACT

+8615901045120; tracymaobao@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Anesthesiologist

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 12, 2025
• Study Start: March 30, 2025
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)