Postoperative PainNCT06704490
Analysis of the Incidence and Risk Factors of Chronic Pain After Cesarean Section
An observational study of Postoperative Pain and Cesarean Section Surgery, run by Huazhong University of Science and Technology at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Postoperative Pain, Cesarean Section Surgery
- What is being tested?
- Cesarean section
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women planning to undergo cesarean section surgery
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji hospital
Wuhan, Hubei, 430030
Xianwei Zhang, Professor, 13296696810, ourpain@163.com
About this study
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.
- Conditions
- Postoperative Pain, Cesarean Section Surgery
- Being tested
- Cesarean section
- Keywords
- postoperative pain, chronic postoperative pain, cesarean section surgery, Postpartum depression
- Medical subject headings
- Pain, Postoperative, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cesarean sectionOther
Observational study without intervention
| Study group | Role | What they receive |
|---|---|---|
| Cesarean section surgery | Observational research Receives: Other: Cesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2024-01-01-2025-01-01
Secondary outcomes (3)
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.
Measured: 2024-2026
Adverse effects of postoperative analgesia
Incidence and the risk factors of adverse effects of postoperative analgesia, especially postoperative nausea and vomiting
Measured: 2024-2026
Checklist for Chronic pain after cesarean section
Types of chronic pain after cesarean section
Measured: 2024-2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start1 Feb 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xianwei Zhang，MD, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704490
- Sponsor's protocol ID
- chronic postoperative pain
- Status last verified
- Nov 2024
- First submitted
- 18 Mar 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 30322586Klemetti 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.
PubMed 19819416Lumbiganon 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.
PubMed 20071021Li 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.
PubMed 28030701Zhang 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.
PubMed 34559941Sharpe 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.
PubMed 31145215
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Incidence and Risk Factors of Chronic Pain After Cesarean Section
- ClinicalTrials.gov ID
- NCT06704490
- Acronym / sponsor ID
- chronic postoperative pain
- Conditions
- Postoperative Pain, Cesarean Section Surgery
- Keywords
- postoperative pain, chronic postoperative pain, cesarean section surgery, Postpartum depression
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cesarean section surgery | – | Other: Cesarean sectionObservational research |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women planning to undergo cesarean section surgery
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cesarean sectionObservational study without intervention | Other | Cesarean section surgery |
Primary outcome
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
3 secondary outcomes
Identification of high-risk factors for postoperative inadequate analgesia and PONV in obstetric patients based on machine learning methods
Time frame: 2024-2026
Adverse effects of postoperative analgesia
Time frame: 2024-2026
Checklist for Chronic pain after cesarean section
Time frame: 2024-2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Results publication: PubMed 30322586Betran 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.
- Results publication: PubMed 19819416Klemetti 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.
- Results publication: PubMed 20071021Lumbiganon 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.
- Results publication: PubMed 28030701Li 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.
- Results publication: PubMed 34559941Zhang 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.
- Results publication: PubMed 31145215Sharpe 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain and Cesarean Section Surgery, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xianwei Zhang, Doctor (13296696810, ourpain@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of chronic pain after caesarean section (time frame: 2024-01-01-2025-01-01). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06704490, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.