Nalbuphine Dosing and Its Impact on Anxiety and Depression in Ectopic Pregnancy Surgery
Status:
NOT_YET_RECRUITING
Trial end date:
2025-10-30
Target enrollment:
Participant gender:
Summary
This prospective, randomized, controlled study aims to evaluate the impact of different doses of nalbuphine on anxiety and depression in patients undergoing surgery for ectopic pregnancy. Ectopic pregnancy, which occurs in approximately 2% of all pregnancies, often requires surgical intervention, leading to potential psychological distress such as anxiety and depression in affected women. Effective postoperative pain management is essential to enhance recovery and reduce emotional disturbances.
The study will involve 165 eligible patients diagnosed with ectopic pregnancy at Jinjiang District Maternal and Child Health Hospital. Participants will be randomly assigned to three groups, each receiving a different concentration of nalbuphine combined with metoclopramide for postoperative analgesia. The primary outcome will focus on changes in anxiety and depression scores measured on postoperative day three, while secondary outcomes will assess pain levels, the use of patient-controlled analgesia (PCA), the necessity for rescue analgesics, and the occurrence of adverse reactions.
Sample size calculations suggest that at least 165 participants are required to achieve adequate statistical power. Data will be analyzed using SPSS 25.0 software, with results expected to provide insights into the effectiveness of nalbuphine in improving postoperative recovery and mental health in women experiencing ectopic pregnancy. The study has received ethical approval and is funded by the Chengdu Medical Research Projects (No. 2023465, 2022548, and 2023304).
Phase:
NA
Details
Lead Sponsor:
Chengdu Jinjiang Maternity and Child Health Hospital