An interventional study of Nalbuphine 0.20mg/ml(total 30 mg) and Nalbuphine 0.27mg/ml(total 40 mg) in Ectopic Pregnancy, Anxiety and Depression, sponsored by Chengdu Jinjiang Maternity and Child Health Hospital. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-08.
Sponsored by Chengdu Jinjiang Maternity and Child Health Hospital · Not applicable, Interventional, and Treatment
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).
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:
This study is designed as a single-center, prospective, randomized, controlled clinical trial conducted at Jinjiang District Maternal and Child Health Hospital. Ethical approval will be obtained, and all participants will provide informed consent.
Interventions:
165 eligible patients will be randomly assigned into three groups (N1, N2, N3), each receiving different doses of nalbuphine combined with metoclopramide for postoperative pain management, with a total volume of 150ml for each group. The groups are as follows:
Patient-controlled analgesia (PCA) will be maintained for 48 hours.
Primary Outcome:
The primary outcome will be the assessment of anxiety and depression scores measured on postoperative day three.
Secondary Outcomes:
Secondary outcomes will include:
Ethics Approval:
This study has received approval from the ethics committee of Chengdu Jinjiang District Maternal and Child Health Hospital (Approval Number: 202312). All participants must sign an informed consent form to ensure the respect of participant rights and data confidentiality. The study will strictly adhere to relevant ethical standards and legal regulations to protect participant safety and privacy.
Funding:
The study is funded by the Chengdu Medical Research Projects (No. 2023465, 2022548, and 2023304).
83 studies on the registry are indexed under Pregnancy, Ectopic; 21 are open to participants now.
This study's planned enrollment of 165 is above the median of 100 across 43 interventional studies indexed under Pregnancy, Ectopic.
Browse Pregnancy, Ectopic studies →Chengdu Jinjiang Maternity and Child Health Hospital is the lead sponsor of 10 studies on the registry; 7 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Nalbuphine 0.20mg/ml(total 30 mg)
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.
Drug: Nalbuphine 0.27mg/ml(total 40 mg)
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.
Drug: Nalbuphine 0.33mg/ml(total 50 mg)
Drug page: Nalbuphine
In 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.
Drug page: Nalbuphine
Participants 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.
Drug page: Nalbuphine
In 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:
Time frame: Day 3 post-surgery
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
Time frame: Postoperative 6 hours, 12 hours, 24 hours, and 48 hours
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.
Time frame: 48 hours post-surgery
Need for Rescue Analgesia
This outcome will document whether patients require additional rescue analgesia postoperatively to assess the adequacy of the initial analgesic regimen.
Time frame: 48 hours post-surgery
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.
Time frame: day 2 post-surgery
Time to Ambulate
This outcome will measure the time taken for patients to ambulate (get out of bed)
Time frame: Perioperative
Time to Flatus
This outcome will measure the time taken to pass gas post-surgery.
Time frame: Perioperative
Number of participants experience feelings of Dizziness
Patients might experience feelings of dizziness or loss of balance. This reaction can lead to discomfort and potential dangers when the patient is standing or walking.
Time frame: day 2 post-surgery
Number of participants experience feelings of Nausea
Patients may experience a sensation of wanting to vomit or feelings of nausea. This can impact their appetite and contribute to further discomfort.
Time frame: day 2 post-surgery
Number of participants experience feelings of Vomiting
In some cases, nausea may develop into vomiting, leading patients to actually expel contents from their stomach. This can affect recovery and may lead to dehydration or electrolyte imbalances.
Time frame: day 2 post-surgery
No study locations are listed for this record.
Plan to share: No — For our study "Effects of Different Doses of Nalbuphine on Anxiety and Depression in Patients Undergoing Ectopic Pregnancy Surgery: A Prospective, Randomized, Controlled Study" we have decided not to share Individual Participant Data (IPD). This decision is due to privacy concerns, data security requirements, ethical approval limitations, legal restrictions, and the study's design which did not accommodate data sharing. We believe this aligns with ethical standards and operational capabilities.
Start is estimated for Jun 2025; primary completion for Oct 2025, 4 months later.
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This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Nalbuphine
Chengdu Jinjiang Maternity and Child Health Hospital