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Effect of nalbuphine on the EC50 and EC95 of ropivacaine for epidural labor analgesia

Effect of nalbuphine on the EC50 and EC95 of ropivacaine for epidural labor analgesia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076379
Enrollment
Unknown
Registered
2023-10-07
Start date
2023-10-08
Completion date
Unknown
Last updated
2023-10-09

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

Conditions

Labor Pain

Interventions

Group1:nalbuphine 0.1mg/ml
Group2:nalbuphine 0.15mg/ml
Group3:nalbuphine 0.2mg/ml
Group4:nalbuphine 0.25mg/ml
Group5:nalbuphine 0.3mg/ml
Control group:None

Sponsors

Women's Hospital School of Medicine Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Parturients aged 18-40 years with healthy singleton pregnancies at term (=37 weeks gestational age), spontaneous onset of labor, latent phase of labor with cervical dilation of 2–5 cm, and painful contractions requiring labor epidural analgesia, without electrolyte disorders as well as infectious, immunologic, Endocrine system diseases.

Exclusion criteria

Exclusion criteria: parturients suffering from psychiatric and central nervous system disorders, liver disease, renal function abnormalities, cardiopulmonary function abnormalities, diabetes mellitus;severe obstetric comorbidities and complications such as pre-eclampsia and eclampsia, hyperemesis gravidarum, placenta previa, placenta previa; stillbirth; neonatal malformation; Parturients with contraindications to neuraxial anesthesia; abnormal coagulation function; recent use of cardiovascular drugs, sedative and analgesic drugs, hormonal drugs, anti-psychotic drugs and anticoagulant drugs; severe hypovolemia and hemodynamic instability, as well as refusing to participate.

Design outcomes

Primary

MeasureTime frame
Number of cases of effective and ineffective labor analgesia in each group ;

Secondary

MeasureTime frame
Total amount of ropivacain consumption in each group;the total number of PCA demands ;Hemodynamic parameters of each group ;VAS score of each group;Ramsay score;Duration of first and second stage of labor;Method of delivery;Bromage score;Incidence of adverse reactions;Apgar score;

Countries

China

Contacts

Public ContactLili Xu

Women's Hospital School of Medicine Zhejiang University

xulili@zju.edu.cn+86 138 5811 5478

Outcome results

None listed

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