Clinical trial NCT07009808: Nalbuphine Dosing and Its Impact on Anxiety and Depression in Ectopic Pregnancy Surgery
Official title: Effects of Different Doses of Nalbuphine on Anxiety and Depression in Patients Undergoing Ectopic Pregnancy Surgery: A Prospective, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ectopic Pregnancy
Anxiety
Depression
Nalbuphine
Keywords: Ectopic Pregnancy
Anxiety
Depression
Nalbuphine
Lead sponsor: Chengdu Jinjiang Maternity and Child Health Hospital
Sponsor class: OTHER
First posted: 2025-06-08
Enrollment: 165
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: 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:

* Group A: Nalbuphine 0.20 mg/ml (total 30 mg)
* Group B: Nalbuphine 0.27 mg/ml (total 40 mg)
* Group C: Nalbuphine 0.33 mg/ml (total 50 mg)

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:

1. Visual Analog Scale (VAS) resting and activity pain scores at multiple time points (T1: 6 hours, T2: 12 hours, T3: 24 hours, T4: 48 hours).
2. Number of PCA button presses.
3. Use and frequency of rescue analgesics.
4. Incidence of adverse reactions such as drowsiness, dizziness, nausea, vomiting, and respiratory depression.
5. Time to mobilization and time to first flatus.

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).

Eligibility criteria: Inclusion Criteria:

1. Confirmed diagnosis of ectopic pregnancy, aged ≥18 years, and with normal psychological status.
2. Patients planned to undergo single-port laparoscopic surgery under general anesthesia, followed by postoperative patient-controlled intravenous analgesia (PCIA).
3. Patients classified as ASA I or II.
4. Able to understand the study process and methods, voluntarily participate, and sign the informed consent form.

Exclusion Criteria:

1. Patients using other analgesic methods or multiple analgesic approaches.
2. Patients with a history of allergies or allergies to anesthetic drugs.
3. Patients with a history of depression or mental illness.
4. Patients with other severe organ dysfunction.
5. Patients unable to operate the intravenous analgesia pump independently.

Primary outcomes:
measure: Postoperative Anxiety and Depression Scores
timeFrame: Day 3 post-surgery
Secondary outcomes:
measure: Visual Analog Scale (VAS) Pain Scores
timeFrame: Postoperative 6 hours, 12 hours, 24 hours, and 48 hours
measure: Effective Presses of the Pain Pump
timeFrame: 48 hours post-surgery
measure: Need for Rescue Analgesia
timeFrame: 48 hours post-surgery
measure: Number of participants experience feelings of drowsiness
timeFrame: day 2 post-surgery
measure: Time to Ambulate
timeFrame: Perioperative
measure: Time to Flatus
timeFrame: Perioperative
measure: Number of participants experience feelings of Dizziness
timeFrame: day 2 post-surgery
measure: Number of participants experience feelings of Nausea
timeFrame: day 2 post-surgery
measure: Number of participants experience feelings of Vomiting
timeFrame: day 2 post-surgery
Other outcomes:
Locations:
Study officials:
References:
citation: Bollig KJ, Friedlander H, Schust DJ. Ectopic Pregnancy and Lifesaving Care. JAMA. 2023 Jun 20;329(23):2086-2087. doi: 10.1001/jama.2023.7292.
citation: Farren J, Jalmbrant M, Falconieri N, Mitchell-Jones N, Bobdiwala S, Al-Memar M, Tapp S, Van Calster B, Wynants L, Timmerman D, Bourne T. Posttraumatic stress, anxiety and depression following miscarriage and ectopic pregnancy: a multicenter, prospective, cohort study. Am J Obstet Gynecol. 2020 Apr;222(4):367.e1-367.e22. doi: 10.1016/j.ajog.2019.10.102. Epub 2019 Dec 13.
citation: Farren J, Jalmbrant M, Falconieri N, Mitchell-Jones N, Bobdiwala S, Al-Memar M, Tapp S, Van Calster B, Wynants L, Timmerman D, Bourne T. Differences in post-traumatic stress, anxiety and depression following miscarriage or ectopic pregnancy between women and their partners: multicenter prospective cohort study. Ultrasound Obstet Gynecol. 2021 Jan;57(1):141-148. doi: 10.1002/uog.23147.
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citation: Akshat S, Ramachandran R, Rewari V, Chandralekha, Trikha A, Sinha R. Morphine versus Nalbuphine for Open Gynaecological Surgery: A Randomized Controlled Double Blinded Trial. Pain Res Treat. 2014;2014:727952. doi: 10.1155/2014/727952. Epub 2014 Apr 14.