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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain; Cesarean Section Surgery
• Intervention / Treatment: Other: Cesarean section

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Xianwei Zhang, Doctor; Phone Number: 13296696810; Email: ourpain@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital
      • Contact: Xianwei Zhang, Professor; Phone Number: 13296696810; Email: ourpain@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women planning to undergo cesarean section surgery

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cesarean section surgery; Observational research	Other: Cesarean section; Observational study without intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of chronic pain after caesarean section	Assessment of chronic postoperative pain by Brief Pain Inventory from 0 to ten, The higher the score, the stronger the pain	2024-01-01-2025-01-01

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology

Publications and helpful links

General Publications

• Betran AP, Temmerman M, Kingdon C, Mohiddin A, Opiyo N, Torloni MR, Zhang J, Musana O, Wanyonyi SZ, Gulmezoglu AM, Downe S. Interventions to reduce unnecessary caesarean sections in healthy women and babies. Lancet. 2018 Oct 13;392(10155):1358-1368. doi: 10.1016/S0140-6736(18)31927-5.
• Klemetti R, Che X, Gao Y, Raven J, Wu Z, Tang S, Hemminki E. Cesarean section delivery among primiparous women in rural China: an emerging epidemic. Am J Obstet Gynecol. 2010 Jan;202(1):65.e1-6. doi: 10.1016/j.ajog.2009.08.032. Epub 2009 Oct 12.
• Lumbiganon P, Laopaiboon M, Gulmezoglu AM, Souza JP, Taneepanichskul S, Ruyan P, Attygalle DE, Shrestha N, Mori R, Nguyen DH, Hoang TB, Rathavy T, Chuyun K, Cheang K, Festin M, Udomprasertgul V, Germar MJ, Yanqiu G, Roy M, Carroli G, Ba-Thike K, Filatova E, Villar J; World Health Organization Global Survey on Maternal and Perinatal Health Research Group. Method of delivery and pregnancy outcomes in Asia: the WHO global survey on maternal and perinatal health 2007-08. Lancet. 2010 Feb 6;375(9713):490-9. doi: 10.1016/S0140-6736(09)61870-5. Epub 2010 Jan 11. Erratum In: Lancet. 2010 Dec 4;376(9756):1902.
• Li HT, Luo S, Trasande L, Hellerstein S, Kang C, Li JX, Zhang Y, Liu JM, Blustein J. Geographic Variations and Temporal Trends in Cesarean Delivery Rates in China, 2008-2014. JAMA. 2017 Jan 3;317(1):69-76. doi: 10.1001/jama.2016.18663.
• Zhang Y, Betran AP, Li X, Liu D, Yuan N, Shang L, Lin W, Tu S, Wang L, Wu X, Zhu T, Zhang Y, Lu Z, Zheng L, Gu C, Fang J, Liu Z, Ma L, Cai Z, Yang X, Li H, Zhang H, Zhao X, Yan L, Wang L, Sun X, Luo Q, Liu L, Zhu J, Qin W, Yao Q, Dong S, Yang Y, Cui Z, He Y, Feng X, He L, Zhang H, Zhang L, Wang X, Souza JP, Qi H, Duan T, Zhang J. What is an appropriate caesarean delivery rate for China: a multicentre survey. BJOG. 2022 Jan;129(1):138-147. doi: 10.1111/1471-0528.16951. Epub 2021 Oct 26.
• Sharpe EE, Booth JL, Houle TT, Pan PH, Harris LC, Aschenbrenner CA, Eisenach JC. Recovery of physical activity after cesarean delivery and its relationship with pain. Pain. 2019 Oct;160(10):2350-2357. doi: 10.1097/j.pain.0000000000001628.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: November 24, 2024
• First Posted (Estimated): November 26, 2024

Study Record Updates

• Last Update Posted (Estimated): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 24, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: postoperative pain; Postpartum depression; chronic postoperative pain; cesarean section surgery
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Chronic Pain
• Other Study ID Numbers: chronic postoperative pain

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No