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Comparison of Postoperative Pain Between Patients Received Primary and Repeated Caesarean Section

Sponsor
Xinqiao Hospital of Chongqing (Other)
Overall Status
Completed
CT.gov ID
NCT03009955
Collaborator
(none)
168
Enrollment
1
Location
6
Duration (Months)
28.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    168 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Comparison of Postoperative Pain Between Patients Received Primary and Repeated Caesarean Section
    Study Start Date :
    Dec 1, 2016
    Actual Primary Completion Date :
    May 1, 2017
    Actual Study Completion Date :
    Jun 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Group P

    patients who received primary caesarean section
    Group R

    patients who received repeated caesarean section

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. Pain intensity at 3 to 7 days after the surgery [At 3 to 7 days after the surgery]

    2. Pain intensity at 4 weeks after the surgery [At 4 weeks after the surgery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Xinqiao Hospital, Third Military Medical University Chongqing Chongqing China 400037

    Sponsors and Collaborators

    • Xinqiao Hospital of Chongqing

    Investigators

    • Principal Investigator: Hong Li, M.D., Department of Anesthesiology, Xinqiao Hospital, Third Military Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hong Li, Director, Department of Anesthesiology, Xinqiao Hospital of Chongqing
    ClinicalTrials.gov Identifier:
    NCT03009955
    Other Study ID Numbers:
    • Postoperative pain
    First Posted:
    Jan 4, 2017
    Last Update Posted:
    Jul 6, 2017
    Last Verified:
    Jul 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Pain, Postoperative

    Study Results

    No Results Posted as of Jul 6, 2017