Patiet Controlled Analgesia, Postoperative Pain
Conditions
Keywords
postoperative pain, Cesarean section surgery, Hydromorphone, Nalbuphine, Predictive Model, patiet controlled analgesia
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.
Interventions
Observational study without intervention
Sponsors
Huazhong University of Science and Technology
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Usage of patient controlled analgesia (PCA) | 2024-12-05-2025-05-30 | Assessment of PCA Press Count and PCA Consumption |
| 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 |
| Diclofenac sodium dosage | 2024-12-05-2025-05-30 | Diclofenac sodium dosage after caesarean section |
| Adverse effects of postoperative analgesia | 2024-12-05-2025-05-30 | Incidence and the risk factors of adverse effects of postoperative analgesia |
Other
| Measure | Time frame | Description |
|---|---|---|
| Regression analysis of inadequate analgesia | 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. |
| Acute postoperative pain predictive model | 2024-12-05-2025-05-30 | Development and validation of a predictive model for acute postoperative pain after cesarean section. |
Countries
China
Outcome results
None listed