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

• Conditions: Postoperative Pain; Patiet Controlled Analgesia

• Registration Number: NCT06716359
• Lead Sponsor: Huazhong University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-21
• Study First Submitted QC: 2024-11-29
• Study Start: 2024-12-04
• Study First Posted: 2024-12-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-13
• Primary Completion: 2025-05-20
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 240

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of pain after caesarean section	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
Incidence of inadequate analgesia	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 Outcome Measures

Name	Time	Method
Adverse effects of postoperative analgesia	2024-12-05-2025-05-30	Incidence and the risk factors of adverse effects of postoperative analgesia
Usage of patient controlled analgesia (PCA)	2024-12-05-2025-05-30	Assessment of PCA Press Count and PCA Consumption
Diclofenac sodium dosage	2024-12-05-2025-05-30	Diclofenac sodium dosage after caesarean section
Patient satisfaction	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.
Length of hospital stay	2024-12-05-2025-05-30	Assessment of the length of hospital stay

Trial Locations

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China