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

July 3, 2017 updated by: Hong Li, Xinqiao Hospital of Chongqing
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

168

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400037
        • Xinqiao Hospital, Third Military Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Patients who receiving primary and repeated caesarean section.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Group P
patients who received primary caesarean section
Group R
patients who received repeated caesarean section

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain VAS at 4, 8, 12, 24 and 48 hours after the surgery
Time Frame: 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

Outcome Measure
Time Frame
Pain intensity at 3 to 7 days after the surgery
Time Frame: At 3 to 7 days after the surgery
At 3 to 7 days after the surgery
Pain intensity at 4 weeks after the surgery
Time Frame: At 4 weeks after the surgery
At 4 weeks after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinqiao Hospital of Chongqing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

December 30, 2016

First Submitted That Met QC Criteria

December 30, 2016

First Posted (Estimate)

January 4, 2017

Study Record Updates

Last Update Posted (Actual)

July 6, 2017

Last Update Submitted That Met QC Criteria

July 3, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • postoperative pain

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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