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Enrolling by Invitation

NCT Number: NCT06716359

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.

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Key information

Age range

20 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

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

Wuhan, Hubei, 430030, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Observational study without intervention

Other

Observational study without intervention

Primary outcomes

  1. Incidence of pain after caesarean section

    Time frame: 2024-12-05-2025-05-30

    Assessment of chronic postoperative pain by Brief Pain Inventory from 0 to ten, The higher the score, the stronger the pain

  2. Incidence of inadequate analgesia

    Time frame: 2024-12-05-2025-05-30

    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.

Secondary outcomes

  1. Adverse effects of postoperative analgesia

    Time frame: 2024-12-05-2025-05-30

    Incidence and the risk factors of adverse effects of postoperative analgesia

  2. Usage of patient controlled analgesia (PCA)

    Time frame: 2024-12-05-2025-05-30

    Assessment of PCA Press Count and PCA Consumption

  3. Diclofenac sodium dosage

    Time frame: 2024-12-05-2025-05-30

    Diclofenac sodium dosage after caesarean section

  4. Patient satisfaction

    Time frame: 2024-12-05-2025-05-30

    Assessment of patient satisfaction by score from 0 to ten, The higher the score, the more satisfied the patient.

  5. Length of hospital stay

    Time frame: 2024-12-05-2025-05-30

    Assessment of the length of hospital stay

Other outcomes

  1. Regression analysis of inadequate analgesia

    Time frame: 2024-12-05-2025-05-30

    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.

  2. Acute postoperative pain predictive model

    Time frame: 2024-12-05-2025-05-30

    Development and validation of a predictive model for acute postoperative pain after cesarean section.

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 4, 2024
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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