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Intrathecal Bupivacaine versus Bupivacaine plus Fentanyl for Anesthesia for Cesarean Delivery: A Randomized Double Blinded Non-Inferiority Trial

Intrathecal Bupivacaine versus Bupivacaine plus Fentanyl for Anesthesia for Cesarean Delivery: A Randomized Double Blinded Non-Inferiority Trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080830
Enrollment
Unknown
Registered
2024-02-08
Start date
2024-03-04
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Parturients who are scheduled for elective cesarean delivery

Interventions

Group B:Bupivacaine 10.75 mg
Group BF:Bupivacaine 9 mg+ Fentanyl 15 µg

Sponsors

Women's Hospital School of Medicine Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: American Society of Anesthesiologists (ASA) Grade II, normal blood pressure, full-term single pregnancy, planned elective cesarean section, not in labor, suitable for neuraxial anesthesia, and patient informed consent

Exclusion criteria

Exclusion criteria: Known fetal abnormalities, pre-existing or pregnanity-induced hypertension, known cardiovascular or cerebrovascular disease, thrombocytopenia, Coagulation dysfunction, presence of contraindications to intrathecal anesthesia, weight 100kg, height 180cm, inability or refusal to sign informed consent, age <18 , being allergic to bupivacaine or fentanyl

Design outcomes

Primary

MeasureTime frame
Success rate of anesthesia ;

Secondary

MeasureTime frame
Pain;Nausea and vomiting;Pruritus;Hypotension;

Countries

China

Contacts

Public ContactLihong Sun

Women's Hospital School of Medicine Zhejiang University

sunlihong@zju.edu.cn+86 158 6901 2780

Outcome results

None listed

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