Circadian Rhythm Status and CS (Cesarean Section) Postoperative Pain

Circadian Rhythm Clinical Trial

Official title:

Circadian Rhythm Status and CS (Cesarean Section) Postoperative Pain

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05446636
• Other study ID #: Biological rhythm and CS pain
• Status: Not yet recruiting
• Start date: August 14, 2022
• Est. completion date: January 1, 2023

Study information

• Verified date: August 2022
• Source: The Second Affiliated Hospital of Chongqing Medical University
• Contact: HUANG HE, MD
• Phone: (+86)13708385559
• Email: huanghe[@]cqmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 280
• Est. completion date: January 1, 2023
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Circadian Rhythm
• Pain, Postoperative

Intervention

Device:
• Huawei bracelet
Huawei bracelet was used to continuously record maternal respiration, heart rate, temperature and sleep data, and then calculate maternal circadian rhythm state

Locations

Country	Name	City	State
China	Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of moderate and severe pain after cesarean section	number rating scale (NRS) for pain (0=no pain to 10=worst pain) >4	From ending of the surgery to 24hours after cesarean section
Secondary	Pain intensity durig 0 to 6 hours after surgery	number rating scale (NRS) for pain (0=no pain to 10=worst pain)	From ending of the surgery to 6 hours after cesarean section
Secondary	Pain intensity durig 6 to 12 hours after surgery	number rating scale (NRS) for pain (0=no pain to 10=worst pain)	From 6 hours after cesarean section to 12 hours after cesarean section
Secondary	Pain intensity durig 12 to 24 hours after surgery	number rating scale (NRS) for pain (0=no pain to 10=worst pain)	From 12 hours after cesarean section to 24 hours after cesarean section
Secondary	Heart rate variability	Heart rate variability recorded by Huawei bracelet	From the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 week
Secondary	Body temperature variability	Body temperature variability recorded by Huawei bracelet	From the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 week
Secondary	Variability of patients' activity	Variability of patients' activity recorded by Huawei bracelet	From the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 week
Secondary	Percentage of deep sleep	Percentage of deep sleep evaluated by Huawei bracelet	From the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 week
Secondary	Percentage of rapid eye movement sleep	Percentage of rapid eye movement sleep evaluated by Huawei bracelet	From the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 week