At a glance
ClinicalIndex Comparison Record- ✓American Society of Anesthesiologists physical status less than III
- ✓Age 18-40 years
- ✓Body weight less than 110 kg
- ✓Height between 160 and 175 cm
- ✕Twin or multiple pregnancy
- ✕History of two or more prior cesarean sections
- ✕Diabetes or gestational diabetes
- ✕Placenta praevia
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Hyperbaric Bupivacaine Versus Hyperbaric Prilocaine 2% for Cesarean Section Under Spinal Anesthesia: a Randomised Clinical Trial
In Brief
A Phase 3 clinical trial evaluating Hyperbaric bupivacaine and Hyperbaric prilocaine for Pregnant Women and 2 related conditions. Completed, enrolled 40 participants across 2 sites.
Detailed Summary
Over the past 15 years, cesarean delivery is most commonly performed under spinal anesthesia using hyperbaric bupivacaine which provides an adequate sensory and motor block. Despite effective surgical anesthesia, bupivacaine is associated with long duration motor block and dose-dependent maternal hypotension potentially harmful for the fetus. Prilocaine with its new 2% hyperbaric formulation (HP), developed recently, showed rapid onset of action and faster regression of motor block compared to other local anesthetics without noteworthy side-effects when used intrathecally. The aim of this randomized, multicenter, powered clinical trial is to investigate whether HP may be an efficient alternative to hyperbaric bupivacaine for scheduled caesarean delivery under spinal anesthesia, with more rapid rehabilitation and less adverse effects. Our hypothesis is that hyperbaric prilocaine offers shorter motor block and more rapid rehabilitation than bupivacaine.
Study Details
Timeline
Interventions
The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.