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Clinical Trials/NCT06704490
NCT06704490
Recruiting
N/A

Analysis of the Incidence and Risk Factors of Chronic Pain After Cesarean Section

Huazhong University of Science and Technology1 site in 1 country600 target enrollmentFebruary 1, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Postoperative Pain
Sponsor
Huazhong University of Science and Technology
Enrollment
600
Locations
1
Primary Endpoint
Incidence of chronic pain after caesarean section
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Persistent postoperative pain is a globally recognized issue that deserves attention. Cesarean section is one of the surgeries that may cause persistent postoperative pain. PSPP may affect communication between mother and baby, and may lead to postpartum depression, which has a negative impact on the daily activities and quality of life of mothers. It is an important clinical issue.

The main purpose of this study is to (1) prospectively investigate the overall incidence and characteristics of persistent pain after cesarean section at 3, 6, and 12 months after surgery; (2) Use regression analysis and data modeling analysis to evaluate the relationship between perioperative variables and chronic pain in postpartum women undergoing cesarean section; (3) Analyze the relationship between chronic pain after cesarean section and postpartum depression in postpartum women.

Registry
clinicaltrials.gov
Start Date
February 1, 2024
End Date
December 31, 2026
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Xianwei Zhang,MD

Professor

Huazhong University of Science and Technology

Eligibility Criteria

Inclusion Criteria

  • Age range from 20 to 50 years old;
  • ASA grades I to III;
  • Full term pregnancy and planned cesarean section with transverse incision in the lower segment of the uterus;
  • Pregnant women who are willing to participate in this study and sign informed consent forms.

Exclusion Criteria

  • Have a history of dementia, mental illness, or any central nervous system disorder;
  • Pregnant women who are addicted to alcohol and drugs;
  • Difficulty in follow-up or poor patient compliance;
  • Has taken other investigational drugs or participated in other clinical trials in the three months prior to being selected for the study;
  • Serious complications occur during delivery;
  • Unable to cooperate with the research for any reason.

Outcomes

Primary Outcomes

Incidence of chronic pain after caesarean section

Time Frame: 2024-01-01-2025-01-01

Assessment of chronic postoperative pain by Brief Pain Inventory from 0 to ten, The higher the score, the stronger the pain

Secondary Outcomes

  • Identification of high-risk factors for postoperative inadequate analgesia and PONV in obstetric patients based on machine learning methods(2024-2026)
  • Adverse effects of postoperative analgesia(2024-2026)
  • Checklist for Chronic pain after cesarean section(2024-2026)

Study Sites (1)

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