Circadian Rhythm Status and CS (Cesarean Section) Postoperative Pain

• Sponsor: The Second Affiliated Hospital of Chongqing Medical University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05446636
• Collaborator: (none)
• Enrollment: 280
• Location: 1
• Anticipated Duration (Months): 4.6
• Patients Per Site Per Month: 60.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Circadian Rhythm	Device: Huawei bracelet

Study Design

• Study Type: Observational
• Anticipated Enrollment: 280 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Circadian Rhythm Status and CS (Cesarean Section) Postoperative Pain
• Anticipated Study Start Date: Aug 14, 2022
• Anticipated Primary Completion Date: Oct 31, 2022
• Anticipated Study Completion Date: Jan 1, 2023

Outcome Measures

Primary Outcome Measures

1. 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

1. 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)

2. 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)

3. 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)

4. 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

5. 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

6. 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

7. 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

8. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University	Chongqing	Chongqing	China	400010

Sponsors and Collaborators

• The Second Affiliated Hospital of Chongqing Medical University

Investigators

• Study Director: HUANG HE, MD, The Second Affiliated Hospital, Chongqing Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Second Affiliated Hospital of Chongqing Medical University
• ClinicalTrials.gov Identifier: NCT05446636
• Other Study ID Numbers: Biological rhythm and CS pain
• First Posted: Jul 7, 2022
• Last Update Posted: Aug 5, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by The Second Affiliated Hospital of Chongqing Medical University: Circadian Rhythm; Cesarean Section; Pain
• Additional relevant MeSH terms: Pain, Postoperative

Study Results

No Results Posted as of Aug 5, 2022