Nalbuphine Dosing and Its Impact on Anxiety and Depression in Ectopic Pregnancy Surgery

Chengdu Jinjiang Maternity and Child Health Hospital

Status: Not yet enrolling

Conditions: Nalbuphine; Ectopic Pregnancy; Depression; Anxiety

Treatments: Drug: Nalbuphine 0.20mg/ml(total 30 mg); Drug: Nalbuphine 0.33mg/ml(total 50 mg); Drug: Nalbuphine 0.27mg/ml(total 40 mg)

Study type: Interventional

Funder types: Other

Identifiers

NCT07009808

202427

Details and patient eligibility

About

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).

Full 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).

Enrollment: 165 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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165 participants in 3 patient groups

N1 Group

Experimental group

Description:

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.

Treatment:

Drug: Nalbuphine 0.20mg/ml(total 30 mg)

N2 Group

Experimental group

Description:

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.

Treatment:

Drug: Nalbuphine 0.27mg/ml(total 40 mg)

N3 Group

Experimental group

Description:

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.

Treatment:

Drug: Nalbuphine 0.33mg/ml(total 50 mg)