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NCT07009808
Nalbuphine Dosing and Its Impact on Anxiety and Depression in Ectopic Pregnancy Surgery
NA trial testing Nalbuphine 0.20mg/ml(total 30 mg) in Ectopic Pregnancy in 165 participants. Not yet recruiting.
22 October 2025
Quick facts
| Lead sponsor | Chengdu Jinjiang Maternity and Child Health Hospital |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 165 |
| Start date | 20 June 2025 |
| Primary completion | 22 October 2025 |
| Estimated completion | 30 October 2025 |
Drugs / interventions tested
- Nalbuphine 0.20mg/ml(total 30 mg) — full drug profile →
- Nalbuphine 0.27mg/ml(total 40 mg) — full drug profile →
- Nalbuphine 0.33mg/ml(total 50 mg) — full drug profile →
Conditions studied
- Ectopic Pregnancy — all drugs for Ectopic Pregnancy →
- Anxiety — all drugs for Anxiety →
- Depression — all drugs for Depression →
- Nalbuphine — all drugs for Nalbuphine →
Sponsor
Chengdu Jinjiang Maternity and Child Health Hospital
Who can join
18 and older, female only, with Ectopic Pregnancy or Anxiety. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07009808
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Other Chengdu Jinjiang Maternity and Child Health Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07009808 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chengdu Jinjiang Maternity and Child Health Hospital
- Last refreshed: 8 June 2025
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