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

NCT07009808 | Not Yet Recruiting

• 1 other identifier: 202427
• Study Type: interventional
• Target: 165
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Ectopic Pregnancy; Anxiety; Depression; Nalbuphine

Keywords

Ectopic Pregnancy; Anxiety; Depression; Nalbuphine

Outcome Measures

Primary Outcomes (1)

• 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:

  Day 3 post-surgery

Secondary Outcomes (9)

• 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

Study Arms (3)

N1 Group

EXPERIMENTAL

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)

N2 Group

EXPERIMENTAL

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)

N3 Group

EXPERIMENTAL

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)

Interventions

Nalbuphine 0.20mg/ml(total 30 mg) DRUG

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.

N1 Group

Nalbuphine 0.27mg/ml(total 40 mg) DRUG

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.

N2 Group

Nalbuphine 0.33mg/ml(total 50 mg) DRUG

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.

N3 Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study is exclusively for female participants, as ectopic pregnancy is a condition that occurs only in women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chengdu Jinjiang Maternity and Child Health Hospital: lead

Related Publications (5)

• 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.

  PMID: 37261808 BACKGROUND

• 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.

  PMID: 31953115 BACKGROUND

• 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.

  PMID: 33032364 BACKGROUND

• Pan X, Wang J, Lin Z, Dai W, Shi Z. Depression and Anxiety Are Risk Factors for Postoperative Pain-Related Symptoms and Complications in Patients Undergoing Primary Total Knee Arthroplasty in the United States. J Arthroplasty. 2019 Oct;34(10):2337-2346. doi: 10.1016/j.arth.2019.05.035. Epub 2019 May 28.

  PMID: 31229373 BACKGROUND

• 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.

  PMID: 24834352 BACKGROUND

Related Links

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MeSH Terms

Conditions

Pregnancy, Ectopic; Anxiety Disorders; Depression

Interventions

Nalbuphine

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Bo Liu, MS

CONTACT

+8618502846036; liubojjfy@163.com

Fei Jia, MD

CONTACT

+8618581877655; jiafei1980@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Anesthesiology Department

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 8, 2025
• Study Start: June 20, 2025
• Primary Completion: October 22, 2025
• Study Completion: October 30, 2025
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share