Ignite Creation Date:
2024-05-06 @ 9:24 AM
Last Modification Date:
2024-10-26 @ 12:14 PM
Study NCT ID:
NCT02973048
Status:
COMPLETED
Last Update Posted:
2020-07-02
First Post:
2016-07-25
Brief Title:
Hyperbaric Bupivacaine Versus Hyperbaric Prilocaine 2 for Cesarean Section Under Spinal Anesthesia
Sponsor:
Centre Hospitalier Universitaire Saint Pierre
Organization:
Centre Hospitalier Universitaire Saint Pierre
Study Overview
Official Title:
Hyperbaric Bupivacaine Versus Hyperbaric Prilocaine 2 for Cesarean Section Under Spinal Anesthesia a Randomised Clinical Trial
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None