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Cancelled by the investigator. Optimization of the Efficacy and Safety of Nalbuphine Combined with Esketamine for Post-Cesarean Analgesia: A Randomized, Double-Blind, Parallel-Controlled Clinical Study

Optimization of the Efficacy and Safety of Nalbuphine Combined with Esketamine for Post-Cesarean Analgesia: A Randomized, Double-Blind, Parallel-Controlled Clinical Study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096581
Enrollment
Unknown
Registered
2025-01-26
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Cesarean Analgesia

Interventions

Group A:Nalbuphine (1 mg/kg) + Esketamine (1 mg/kg).
Group B:Nalbuphine (1 mg/kg) + Esketamine (2 mg/kg).
Group C:Nalbuphine (2 mg/kg) + Esketamine (1 mg/kg).
Group D:Nalbuphine (2 mg/kg) + Esketamine (2 mg/kg).

Sponsors

Zhuhai People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Voluntary signing of the informed consent form. 2. Elective cesarean delivery under neuraxial anesthesia. 3. Primiparous women with a single fetus. 4. American Society of Anesthesiologists (ASA) physical status classification I–III. 5. Age: 21–45 years. 6. Body mass index (BMI): 20–36 kg/m². 7. Gestational age: 37–42 weeks. 8. No gestational diabetes or gestational hypertension.

Exclusion criteria

Exclusion criteria: 1. Pregnant women with a history of domestic violence. 2. Individuals with a history of mental illness. 3. Severe obstetric complications. 4. Neonates with severe genetic disorders. 5. Contraindications to neuraxial anesthesia. 6. Individuals unable to communicate effectively. 7. Known allergies or contraindications to the medications used in this study. 8. Diagnosed with antenatal depression, defined as an Edinburgh Postnatal Depression 9.Scale (EPDS) score >=10. 9. Considered unsuitable for participation in the study at the discretion of the investigator.

Design outcomes

Primary

MeasureTime frame
Pain Visual Analogue Scale;

Secondary

MeasureTime frame
Edinburgh Postnatal Depression Scale (EPDS) score;Total PCIA consumption, number of successful presses, and cases requiring rescue analgesia.;Time to first ambulation, time to first anal flatus, time to first breastfeeding, number of breastfeeding sessions within 48 hours postoperatively, and time to discharge.;Maternal satisfaction;

Countries

China

Contacts

Public ContactJiuqing Liang

Zhuhai Clinical Medical College of Jinan University(Zhuhai People's Hospital)

jiuqingliang@126.com+86 134 2019 1586

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026