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Clinical study of nalbuphine combined with hydromorphone for PCIA analgesia after gynecological laparoscopic surgery

Clinical study of nalbuphine combined with hydromorphone for PCIA analgesia after gynecological laparoscopic surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800017188
Enrollment
Unknown
Registered
2018-07-17
Start date
2018-07-18
Completion date
Unknown
Last updated
2018-07-23

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

Conditions

Gynecological laparoscopic analgesia

Interventions

1:(0.8mg/ml nalbuphine + 0.1mg/ml dexamethasone+ saline)/100ml PCIA
2:(0.6mg/ml nalbuphine+ 0.02mg/ml hydromorphone + 0.1mg/ml dexamethasone+ saline)/100ml PCIA
3:(0.4mg/ml nalbuphine+ 0.04mg/ml hydromorphone + 0.1mg/ml dexamethasone+ saline)/100ml PCIA
4:(0.2mg/ml nalbuphine+ 0.06mg/ml hydromorphone + 0.1mg/ml dexamethasone+ saline)/100ml PCIA
5:(0.08mg/ml hydromorphone + 0.1mg/ml dexamethasone+ saline)/100ml PCIA

Sponsors

The First Affliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. female patients undergoing gynaecologic surgery (total abdominal hysterectomy, myomectomy, and excision of ovarian tumour); 2. ASA I or II; 3. aged 18-65 years old; 4. BMI 19-29kg/m2; 5. without history of drug abuse, chronic pain, or psychiatric disorders.

Exclusion criteria

Exclusion criteria: 1. Patients who took opioids in the past 3 months; 2. Pruritus history after operation; 3. Poor compliance, unable to complete the research plan; 4. Has participated in clinical drug trials in the past 3 months.

Design outcomes

Primary

MeasureTime frame
VAS;

Secondary

MeasureTime frame
The total consumption of PCIA;Nausea & vomiting;Dizziness & drowsiness;pruritus;

Countries

China

Contacts

Public ContactYanqiu Ai

The First Affliated Hospital of Zhengzhou University

aiyanqiu82@163.com+86 13607690334

Outcome results

None listed

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