Circadian Rhythm Status and CS (Cesarean Section) Postoperative Pain

Recruiting

• Conditions: Circadian Rhythm

• Registration Number: NCT05446636
• Lead Sponsor: The Second Affiliated Hospital of Chongqing Medical University

Brief Summary

Use huawei wristwatch to record maternal rhythm status and record the VAS score after cesarean section under combined spinal-epidural anesthesia. Based on this study the investigators intend to explore the correlation between maternal circadian rhythm status and postoperative pain after cesarean section.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-01
• Study First Submitted QC: 2022-07-03
• Study First Posted: 2022-07-07
• Study Start: 2023-02-14
• Status Verified: 2024-06
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 280

Inclusion Criteria

• Age 20 to 45
• ASA(American society of anesthesiologists) status II-III
• 37-42 weeks gestation
• undergo elective cesarean section with subarachnoid anesthesia
• participate in this study and sign informed consent

Exclusion Criteria

• Patients with contraindications of combined spinal and epidural anesthesia
• Patients with severe systemic disease
• Alcoholism and long-term use of anti-inflammatory and analgesic drugs
• Patients who were unable to cooperate or refused to participate in the trial
• with psychiatric disorder
• researchers considered unsuitable to participate in or unable to cooperate with the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of moderate and severe pain after cesarean section	From ending of the surgery to 24hours after cesarean section	number rating scale (NRS) for pain (0=no pain to 10=worst pain) \>4

Secondary Outcome Measures

Name	Time	Method
Pain intensity durig 6 to 12 hours after surgery	From 6 hours after cesarean section to 12 hours after cesarean section	number rating scale (NRS) for pain (0=no pain to 10=worst pain)
Body temperature variability	From the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 week	Body temperature variability recorded by Huawei bracelet
Percentage of deep sleep	From the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 week	Percentage of deep sleep evaluated by Huawei bracelet
Pain intensity durig 0 to 6 hours after surgery	From ending of the surgery to 6 hours after cesarean section	number rating scale (NRS) for pain (0=no pain to 10=worst pain)
Pain intensity durig 12 to 24 hours after surgery	From 12 hours after cesarean section to 24 hours after cesarean section	number rating scale (NRS) for pain (0=no pain to 10=worst pain)
Variability of patients' activity	From the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 week	Variability of patients' activity recorded by Huawei bracelet
Heart rate variability	From the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 week	Heart rate variability recorded by Huawei bracelet
Percentage of rapid eye movement sleep	From the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 week	Percentage of rapid eye movement sleep evaluated by Huawei bracelet

Trial Locations

Locations (1)

Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China