Effects of Different Doses of Nalbuphine on Anxiety and Depression in Patients Undergoing Ectopic Pregnancy Surgery: A Prospective, Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 165
- 主要终点
- Postoperative Anxiety and Depression Scores
研究概览
简要总结
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).
详细描述
Background:
Ectopic pregnancy occurs when a fertilized egg implants outside the uterine cavity, affecting approximately 2% of all pregnancies. Surgical intervention is the primary treatment, which can lead to significant psychological effects, including anxiety and depression. Studies indicate that patients may experience various emotional disturbances post-surgery, negatively impacting their social adaptability and interpersonal relationships. Effective postoperative pain management is crucial for recovery and may also help alleviate these emotional challenges. Nalbuphine, an opioid receptor agonist-antagonist that primarily acts on the kappa receptor, has been shown to provide pain relief with a lower incidence of respiratory depression and may have a positive impact on mental health compared to traditional opioids.
Objective:
The main objective is to investigate the effects of different concentrations of nalbuphine on anxiety and depression in patients with ectopic pregnancy post-surgery, focusing on changes in anxiety and depression scores on postoperative day three. The secondary objective is to compare the postoperative analgesic effects and the incidence of adverse reactions associated with different concentrations of nalbuphine.
Methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This study employs a randomized, double-blind design to ensure that both the participants and the assessors are unaware of their respective treatment assignments. All patients will be randomly assigned to three groups, receiving different concentrations of nalbuphine via a pain management pump, while the researchers conducting postoperative evaluations (including anxiety, depression, and pain scores) will remain blind to the specific group assignments. Data analysis will also be conducted in a blinded manner to minimize bias. This comprehensive masking approach aims to ensure the objectivity and reliability of the study's results, accurately assessing the impact of nalbuphine on postoperative psychological and pain management in patients with ectopic pregnancy.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of ectopic pregnancy, aged ≥18 years, and with normal psychological status.
- •Patients planned to undergo single-port laparoscopic surgery under general anesthesia, followed by postoperative patient-controlled intravenous analgesia (PCIA).
- •Patients classified as ASA I or II.
- •Able to understand the study process and methods, voluntarily participate, and sign the informed consent form.
排除标准
- •Patients using other analgesic methods or multiple analgesic approaches.
- •Patients with a history of allergies or allergies to anesthetic drugs.
- •Patients with a history of depression or mental illness.
- •Patients with other severe organ dysfunction.
- •Patients unable to operate the intravenous analgesia pump independently.
研究组 & 干预措施
N1 Group
Patients in this group will receive Nalbuphine at a concentration of 0.20 mg/ml, totaling 30 mg, combined with 10 mg of Metoclopramide for postoperative analgesia. This group aims to evaluate the effects of this specific dosing on anxiety and depression levels following ectopic pregnancy surgery.
干预措施: Nalbuphine 0.20mg/ml(total 30 mg) (Drug)
N3 Group
Individuals in this group will receive Nalbuphine at a concentration of 0.33 mg/ml for a total of 50 mg, paired with 10 mg of Metoclopramide for effective postoperative analgesia. This group will help determine the effects of this higher dosage on levels of anxiety and depression after surgery for ectopic pregnancy.
干预措施: Nalbuphine 0.33mg/ml(total 50 mg) (Drug)
N2 Group
articipants in this group will be administered Nalbuphine at a concentration of 0.27 mg/ml, totaling 40 mg, along with 10 mg of Metoclopramide for postoperative pain management. The focus will be on assessing the impact of this dosage on the patients' anxiety and depression scores post-surgery.
干预措施: Nalbuphine 0.27mg/ml(total 40 mg) (Drug)
结局指标
主要结局
Postoperative Anxiety and Depression Scores
时间窗: Day 3 post-surgery
The primary outcome of this study is to evaluate the levels of anxiety and depression in patients following surgery for ectopic pregnancy. This will be assessed using the Hospital Anxiety and Depression Scale (HADS) at the following specific time point:
次要结局
- Time to Flatus(Perioperative)
- Number of participants experience feelings of Nausea(day 2 post-surgery)
- Number of participants experience feelings of Vomiting(day 2 post-surgery)
- Visual Analog Scale (VAS) Pain Scores(Postoperative 6 hours, 12 hours, 24 hours, and 48 hours)
- Effective Presses of the Pain Pump(48 hours post-surgery)
- Need for Rescue Analgesia(48 hours post-surgery)
- Number of participants experience feelings of drowsiness(day 2 post-surgery)
- Time to Ambulate(Perioperative)
- Number of participants experience feelings of Dizziness(day 2 post-surgery)
研究者
Fei Jia
Director of Anesthesiology Department
Chengdu Jinjiang Maternity and Child Health Hospital