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

NCT06716359 | Enrolling By Invitation

• 1 other identifier: Acute postoperative pain
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain; Patiet Controlled Analgesia

Keywords

postoperative pain; Cesarean section surgery; Hydromorphone; Nalbuphine; Predictive Model; patiet controlled analgesia

Outcome Measures

Primary Outcomes (2)

• Incidence of 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

  2024-12-05-2025-05-30

• Incidence of inadequate analgesia

  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 inadequate analgesia.

  2024-12-05-2025-05-30

Secondary Outcomes (5)

• Adverse effects of postoperative analgesia

  2024-12-05-2025-05-30

• Usage of patient controlled analgesia (PCA)

  2024-12-05-2025-05-30

• Diclofenac sodium dosage

  2024-12-05-2025-05-30

• Patient satisfaction

  2024-12-05-2025-05-30

• Length of hospital stay

  2024-12-05-2025-05-30

Other Outcomes (2)

• Regression analysis of inadequate analgesia

  2024-12-05-2025-05-30

• Acute postoperative pain predictive model

  2024-12-05-2025-05-30

Study Arms (1)

Cesarean section surgery

Observational study

Other: Observational study without intervention

Interventions

Observational study without intervention OTHER

Observational study without intervention

Cesarean section surgery

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women planning to undergo cesarean section surgery

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

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

Wuhan, Hubei, 430030, China

Location

Related Publications (5)

• 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.

  PMID: 31145215 BACKGROUND

• 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.

  PMID: 34559941 BACKGROUND

• 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.

  PMID: 28030701 BACKGROUND

• 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.

  PMID: 20071021 BACKGROUND

• 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.

  PMID: 19819416 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Observation; Methods

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: December 4, 2024
• Study Start: December 4, 2024
• Primary Completion: May 20, 2025
• Study Completion: May 31, 2025
• Last Updated: April 13, 2025

Record last verified: 2024-11

Locations

CN (1)