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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03009955
Other study ID # Postoperative pain
Secondary ID
Status Completed
Phase N/A
First received December 30, 2016
Last updated July 3, 2017
Start date December 2016
Est. completion date June 2017

Study information

Verified date July 2017
Source Xinqiao Hospital of Chongqing
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To everyone knows, more and more patients received repeated caesarean section in China. However, at present it is not known what is it like about their postoperative pain intensity, and is it different from those patients who received primary caesarean section. Thus through postoperative follow-up, the current study aimed to investigate and compare the postoperative pain between patients received primary and repeated caesarean section.


Description:

According to whether or not to receive repeated caesarean patients were grouped into group P or group R. For all maternal,standardized epidural anesthesia and caesarean section were performed. Then the pain VAS scores and Ramsay scores at 4h, 8h, 12h, 24h and 48h after the surgery were recorded. And sleep quality at 1 day and 2 day after the surgery were recorded. In addition, pain situation at 1 week and 4 weeks after the surgery was followed up.


Recruitment information / eligibility

Status Completed
Enrollment 168
Est. completion date June 2017
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria:

- single birth

- full-term pregnancy

- in accordance with cesarean section indications

- transverse incision of lower uterine segment

Exclusion Criteria:

- history of dementia, psychiatric illness or any diseases of central nervous system

- accompanying liver or kidney function deficiency

- alcoholism and drug dependence

- patients previously included in this study or currently included in the other clinical study

- patients who have second surgery during the study period

- difficult to follow up or patients with poor compliance

- history of chronic pain

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Xinqiao Hospital, Third Military Medical University Chongqing Chongqing

Sponsors (1)

Lead Sponsor Collaborator
Xinqiao Hospital of Chongqing

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain VAS at 4, 8, 12, 24 and 48 hours after the surgery At 4, 8, 12, 24 and 48 hours after the surgery
Secondary Pain intensity at 3 to 7 days after the surgery At 3 to 7 days after the surgery
Secondary Pain intensity at 4 weeks after the surgery At 4 weeks after the surgery
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