Comparison of the Effects of Hydromorphone and Nalbuphine Patient Controlled Analgesia in Postoperative Pain After Cesarean Section

NCT ID: NCT06716359

Last Updated: 2025-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-04

Study Completion Date

2025-05-31

Brief Summary

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Cesarean section is an essential surgical procedure in obstetrics, which not only addresses dystocia and certain obstetric syndromes, ensuring the safety of the maternal participants, but also increases perinatal survival rates and can save the mother's life. However, the surgical trauma and uterine contractions resulting from cesarean delivery lead to severe pain, which can hinder the mother's postoperative recovery and negatively affect her mental health. Therefore, improving postoperative pain management and addressing issues such as depression and anxiety are crucial challenges in clinical practice today.

Patient-controlled intravenous analgesia (PCA) is widely used in postoperative pain management after cesarean section due to its ability to maintain the minimum effective drug concentration, minimal fluctuation in drug levels, ease of management, and no restriction on activity. However, research on the effects and adverse reactions of hydromorphone and nalbuphine for postoperative pain relief in cesarean section is limited.

In this study, the investigators aim to compare the effects of hydromorphone hydrochloride and nalbuphine in obstetric PCA and examine how various clinical factors influence pain outcomes and adverse reactions. Based on multivariate analysis, the investigators further aim to construct and validate a predictive model for poor analgesic outcomes. To develop more personalized strategies for postoperative pain management following cesarean section, more personalized guidance strategies for postoperative pain management following cesarean section.

Detailed Description

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Conditions

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Postoperative Pain Patiet Controlled Analgesia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Cesarean section surgery

Observational study

Observational study without intervention

Intervention Type OTHER

Observational study without intervention

Interventions

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Observational study without intervention

Observational study without intervention

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Xianwei Zhang,MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 31145215 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34559941 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28030701 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20071021 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19819416 (View on PubMed)

Other Identifiers

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Acute postoperative pain

Identifier Type: -

Identifier Source: org_study_id

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