drugset / Trial / NCT03219086

Spinal Prilocaine for Caesarian Sections

NCT03219086

RandomizedParallel-groupTriple-blindOther

Summary

Prilocaine theoretically could provide faster onset because of its lower pKa (7,7) compared to bupivacaine (8,1). The primary objective of this prospective double blind randomized trial is to determine block onset of spinal hyperbaric prilocaine compared to bupivacaine, both with a small dose of sufentanyl as an additive.The primary hypothesis is that a significant larger amount of patients will gain surgical readiness within 8 minutes after spinal injection of prilocaine with sufentanyl compared to bupivacaine with sufentanyl. Surgical readiness is defined as a sensory block level of T5 tested by loss of cold sensation.

Timeline

Start
2017-08-01
Primary completion
2022-05-01
Completion
2022-05-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bupivacaine Other / unclassified 7.5 mg Other
Comparator prilocaine Small molecule 50 mg Other
Comparator Sufentanil Other / unclassified 2.5 ug Other

Indications

No indication recorded.