Effect of Perioperative Sleep Quality on Chronic Post-Surgical Pain

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Not yet enrolling

Conditions: Chronic Post-Surgical Pain

Study type: Observational

Funder types: Other

Identifiers

NCT06871891

K7648

Details and patient eligibility

About

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).

Enrollment: 1,138 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

1,138 participants in 1 patient group

SLEEP-CPSP Cohort