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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Postoperative Pain; Patiet Controlled Analgesia
• Intervention / Treatment: Other: Observational study without intervention

• Study Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

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 study	Other: Observational study without intervention; Observational study without intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse effects of postoperative analgesia	Incidence and the risk factors of adverse effects of postoperative analgesia	2024-12-05-2025-05-30
Usage of patient controlled analgesia (PCA)	Assessment of PCA Press Count and PCA Consumption	2024-12-05-2025-05-30
Diclofenac sodium dosage	Diclofenac sodium dosage after caesarean section	2024-12-05-2025-05-30
Patient satisfaction	Assessment of patient satisfaction by score from 0 to ten, The higher the score, the more satisfied the patient.	2024-12-05-2025-05-30
Length of hospital stay	Assessment of the length of hospital stay	2024-12-05-2025-05-30

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Regression analysis of inadequate analgesia	Univariate and multivariate regression analysis of inadequate postoperative 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
Acute postoperative pain predictive model	Development and validation of a predictive model for acute postoperative pain after cesarean section.	2024-12-05-2025-05-30

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2024
• Primary Completion (Estimated): May 20, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: November 21, 2024
• First Submitted That Met QC Criteria: November 29, 2024
• First Posted (Actual): December 4, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2025
• Last Update Submitted That Met QC Criteria: April 10, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: postoperative pain; Hydromorphone; Nalbuphine; Predictive Model; Cesarean section surgery; patiet controlled analgesia
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative
• Other Study ID Numbers: Acute 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
• product manufactured in and exported from the U.S.: No