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

Recruiting

• Conditions: Postoperative Pain; Cesarean Section Surgery

• Registration Number: NCT06704490
• Lead Sponsor: Huazhong University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-01
• Study First Submitted: 2024-03-18
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-24
• Last Update Submitted: 2024-11-24
• Study First Posted: 2024-11-26
• Last Update Posted: 2024-11-26
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of chronic pain after caesarean section	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 Outcome Measures

Name	Time	Method
Identification of high-risk factors for postoperative inadequate analgesia and PONV in obstetric patients based on machine learning methods	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.
Adverse effects of postoperative analgesia	2024-2026	Incidence and the risk factors of adverse effects of postoperative analgesia, especially postoperative nausea and vomiting
Checklist for Chronic pain after cesarean section	2024-2026	Types of chronic pain after cesarean section

Trial Locations

Locations (1)

Tongji hospital; 🇨🇳 Wuhan, Hubei, China