Intrathecal bupivacaine versus bupivacaine plus fentanyl for anaesthesia for Caesarean delivery: a randomised double-blind noninferiority trial
Primary resultResult — go to the resultAbsolute difference 1.9% 95% CI −2.0% to 5.9%Authors' conclusion
Under the condition of this study, use of a higher dose of intrathecal bupivacaine was noninferior to bupivacaine plus fentanyl for providing effective anaesthesia for Caesarean delivery.
Study context
- Population
- Women having elective Caesarean delivery under combined spinal-epidural anaesthesia
- Participants
- 626 women
- Comparison
- Bupivacaine vs Bupivacaine plus fentanyl
- Primary endpoint
- Effective anaesthesia (T5 sensory block within 10 min and no intraoperative pain requiring treatment within the first 45 min)
Methodological detailsdouble-blinded, noninferiority
- Double-blinded
- Noninferiority
Primary result
As reported in the abstract
Absolute difference
1.9%
95% CI −2.0% to 5.9%
P = 0.003
By group
Bupivacaine vs Bupivacaine plus fentanyl
absolute difference 1.9% (95% CI −2.0% to 5.9%); P = 0.003
Secondary outcomes
Intraoperative pain, nausea and vomiting, hypotension
- No difference between groups
Safety
Pruritus · greater with bupivacaine plus fentanyl
P < 0.001
Original publication
Intrathecal bupivacaine versus bupivacaine plus fentanyl for anaesthesia for Caesarean delivery: a randomised double-blind noninferiority trial. Br J Anaesth. Published 13 November 2025. doi:10.
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