Clinical trial NCT05446636: Circadian Rhythm Status and CS (Cesarean Section) Postoperative Pain
Official title: Circadian Rhythm Status and CS (Cesarean Section) Postoperative Pain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Circadian Rhythm
Keywords: Circadian Rhythm
Cesarean Section
Pain
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 280
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant women

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of moderate and severe pain after cesarean section
timeFrame: From ending of the surgery to 24hours after cesarean section
Secondary outcomes:
measure: Pain intensity durig 0 to 6 hours after surgery
timeFrame: From ending of the surgery to 6 hours after cesarean section
measure: Pain intensity durig 6 to 12 hours after surgery
timeFrame: From 6 hours after cesarean section to 12 hours after cesarean section
measure: Pain intensity durig 12 to 24 hours after surgery
timeFrame: From 12 hours after cesarean section to 24 hours after cesarean section
measure: Heart rate variability
timeFrame: From the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 week
measure: Body temperature variability
timeFrame: From the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 week
measure: Variability of patients' activity
timeFrame: From the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 week
measure: Percentage of deep sleep
timeFrame: From the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 week
measure: Percentage of rapid eye movement sleep
timeFrame: From the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 week
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
state: Chongqing
Study officials:
affiliation: The Second Affiliated Hospital, Chongqing Medical University
name: Guangyou Duan, MD
role: STUDY_DIRECTOR
References: