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NCT Number: NCT06704490

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

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.

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Key information

Conditions

Postoperative Pain Cesarean Section Surgery Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Pregnancy Complications Puerperal Disorders Signs and Symptoms Urogenital Diseases

Age range

20 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Tongji hospital

Wuhan, Hubei, 430030, China

Location status: Recruiting

Location contact

Xianwei Zhang, Professor

CONTACT

[email protected]

13296696810

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cesarean section

Other

Observational study without intervention

Primary outcomes

  1. 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

  1. Identification of high-risk factors for postoperative inadequate analgesia and PONV in obstetric patients based on machine learning methods

    Time frame: 2024-2026

    Postoperative pain is represented by NRS score (0-10). The higher the NRS score, the more severe the pain. A NRS score of ≥ 4 is considered insufficient postoperative analgesia. Analyzed the predictive value of 42 variables, including preoperative, intraoperative, and postoperative variables, for postoperative inadequate analgesia.

  2. Adverse effects of postoperative analgesia

    Time frame: 2024-2026

    Incidence and the risk factors of adverse effects of postoperative analgesia, especially postoperative nausea and vomiting

  3. Checklist for Chronic pain after cesarean section

    Time frame: 2024-2026

    Types of chronic pain after cesarean section

Study contacts

Contact information is provided by the study sponsor or research team.

Xianwei Zhang, Doctor

CONTACT

[email protected]

13296696810

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 26, 2024
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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