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).
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.
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.
Parallel
Nalbuphine 0.20mg/ml(total 30 mg)
DrugIn this group, participants will receive an intravenous infusion of Nalbuphine at a concentration of 0.20 mg/ml, which delivers a total of 30 mg over the course of 48 hours. Additionally, 10 mg of Metoclopramide will be administered to manage potential postoperative nausea. This intervention aims to assess the analgesic efficacy and its subsequent effect on psychological outcomes, specifically anxiety and depression, in patients undergoing surgery for ectopic pregnancy.
Nalbuphine 0.27mg/ml(total 40 mg)
DrugParticipants assigned to this group will be treated with an intravenous infusion of Nalbuphine at a concentration of 0.27 mg/ml, resulting in a total dosage of 40 mg administered during the 48-hour postoperative period. They will also receive 10 mg of Metoclopramide to mitigate nausea and vomiting. This intervention is designed to evaluate the effectiveness of this dose in pain management and its influence on anxiety and depression levels post-surgery.
Nalbuphine 0.33mg/ml(total 50 mg)
DrugIn this group, subjects will receive Nalbuphine at a concentration of 0.33 mg/ml, totaling 50 mg, delivered through intravenous infusion for 48 hours. Along with this, 10 mg of Metoclopramide will be included to address potential postoperative discomfort. This intervention seeks to explore how this higher concentration impacts pain relief and subsequent psychological effects, specifically targeting anxiety and depression following ectopic pregnancy surgery.
Postoperative Anxiety and Depression Scores
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:
Visual Analog Scale (VAS) Pain Scores
This study will utilize the Visual Analog Scale (VAS) to assess pain levels in patients both at rest and during activity. Pain scores will be measured at the following specific time points to evaluate the efficacy of different dosages of nalbuphine in managing postoperative pain: T1: 6 hours post-surgery T2: 12 hours post-surgery T3: 24 hours post-surgery T4: 48 hours post-surgery
Effective Presses of the Pain Pump
The number of effective presses of the pain pump will be recorded for each patient during their hospital stay to evaluate the effectiveness of the pain pump in alleviating postoperative pain.
Need for Rescue Analgesia
This outcome will document whether patients require additional rescue analgesia postoperatively to assess the adequacy of the initial analgesic regimen.
Number of participants experience feelings of drowsiness
Patients may feel unusually tired or sleepy after surgery. This can affect their attention and reaction times, increasing the risk of falls or other accidents.
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