Ectopic PregnancyNCT07009808
Nalbuphine Dosing and Its Impact on Anxiety and Depression in Ectopic Pregnancy Surgery
A study testing Nalbuphine 0.20mg/ml(total 30 mg), Nalbuphine 0.27mg/ml(total 40 mg) and Nalbuphine 0.33mg/ml(total 50 mg) in people with Ectopic Pregnancy and Anxiety, run by Chengdu Jinjiang Maternity and Child Health Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ectopic Pregnancy, Anxiety, Depression
- What is being tested?
- Nalbuphine 0.20mg/ml(total 30 mg), Nalbuphine 0.27mg/ml(total 40 mg) and Nalbuphine 0.33mg/ml(total 50 mg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2025to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Different Doses of Nalbuphine on Anxiety and Depression in Patients Undergoing Ectopic Pregnancy Surgery: A Prospective, Randomized, Controlled Study
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).
Read the 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:
- 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).
- Number of PCA button presses.
- Use and frequency of rescue analgesics.
- Incidence of adverse reactions such as drowsiness, dizziness, nausea, vomiting, and respiratory depression.
- 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).
- Conditions
- Ectopic Pregnancy, Anxiety, Depression, Nalbuphine
- Being tested
- Nalbuphine 0.20mg/ml(total 30 mg), Nalbuphine 0.27mg/ml(total 40 mg), Nalbuphine 0.33mg/ml(total 50 mg)
- Keywords
- Ectopic Pregnancy, Anxiety, Depression, Nalbuphine
- Medical subject headings
- Pregnancy, Ectopic, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Nalbuphine 0.33mg/ml(total 50 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
Measured: Day 3 post-surgery
Secondary outcomes (9)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: day 2 post-surgery
Time to Ambulate
This outcome will measure the time taken for patients to ambulate (get out of bed)
Measured: Perioperative
Time to Flatus
This outcome will measure the time taken to pass gas post-surgery.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: day 2 post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start20 Jun 2025 (estimated)
- Primary completion22 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ectopic PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Jinjiang Maternity and Child Health Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fei Jia, Chengdu Jinjiang Maternity and Child Health Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009808
- Sponsor's protocol ID
- 202427
- Status last verified
- Jun 2025
- First submitted
- 27 May 2025
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 37261808Farren 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.
PubMed 31953115Farren 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.
PubMed 33032364Pan 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.
PubMed 31229373Akshat 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.
PubMed 24834352
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Doses of Nalbuphine on Anxiety and Depression in Patients Undergoing Ectopic Pregnancy Surgery: A Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT07009808
- Acronym / sponsor ID
- 202427
- Conditions
- Ectopic Pregnancy, Anxiety, Depression, Nalbuphine
- Keywords
- Ectopic Pregnancy, Anxiety, Depression, Nalbuphine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Chengdu Jinjiang Maternity and Child Health HospitalUniversity, hospital or other
- Study start
- 20 Jun 2025 (estimated)
- Primary completion
- 22 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- Number of PCA button presses.
- Use and frequency of rescue analgesics.
- Incidence of adverse reactions such as drowsiness, dizziness, nausea, vomiting, and respiratory depression.
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| N1 Group | Experimental | Drug: Nalbuphine 0.20mg/ml(total 30 mg)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. |
| N2 Group | Experimental | Drug: Nalbuphine 0.27mg/ml(total 40 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. |
| N3 Group | Experimental | Drug: Nalbuphine 0.33mg/ml(total 50 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nalbuphine 0.20mg/ml(total 30 mg)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 | N1 Group |
| Nalbuphine 0.27mg/ml(total 40 mg)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 | N2 Group |
| Nalbuphine 0.33mg/ml(total 50 mg)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. | Drug | N3 Group |
Primary outcome
Postoperative Anxiety and Depression Scores
Time frame: Day 3 post-surgery
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:
9 secondary outcomes
Visual Analog Scale (VAS) Pain Scores
Time frame: Postoperative 6 hours, 12 hours, 24 hours, and 48 hours
Effective Presses of the Pain Pump
Time frame: 48 hours post-surgery
Need for Rescue Analgesia
Time frame: 48 hours post-surgery
Number of participants experience feelings of drowsiness
Time frame: day 2 post-surgery
Time to Ambulate
Time frame: Perioperative
Time to Flatus
Time frame: Perioperative
Number of participants experience feelings of Dizziness
Time frame: day 2 post-surgery
Number of participants experience feelings of Nausea
Time frame: day 2 post-surgery
Number of participants experience feelings of Vomiting
Time frame: day 2 post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Background: PubMed 37261808Bollig KJ, Friedlander H, Schust DJ. Ectopic Pregnancy and Lifesaving Care. JAMA. 2023 Jun 20;329(23):2086-2087. doi: 10.1001/jama.2023.7292.
- Background: PubMed 31953115Farren 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.
- Background: PubMed 33032364Farren 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.
- Background: PubMed 31229373Pan 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.
- Background: PubMed 24834352Akshat 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Nalbuphine 0.20mg/ml(total 30 mg), Nalbuphine 0.27mg/ml(total 40 mg) and Nalbuphine 0.33mg/ml(total 50 mg) in people with Ectopic Pregnancy and Anxiety, run by Chengdu Jinjiang Maternity and Child Health Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bo Liu, MS (+8618502846036, liubojjfy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Anxiety and Depression Scores (time frame: Day 3 post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07009808, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.