Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00332735
Status:
COMPLETED
Last Update Posted:
2007-04-19
First Post:
2006-05-31
Brief Title:
Spinal Anesthesia With Articaine and Bupivacaine for Outpatient Lower Limb Surgery
Sponsor:
Reinier de Graaf Groep
Organization:
Reinier de Graaf Groep
Study Overview
Official Title:
Spinal Anesthesia With 5 Articaine and 05 Bupivacaine for Outpatient Lower Limb Surgery A Double-Blind Randomised Clinical Trial
Status:
COMPLETED
Status Verified Date:
2007-04
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:
The purpose of the trial is to compare two local anesthetics articaine and bupivacaine for outpatient lower limb surgery Onset and recovery times of sensory and motor blockade will be compared
Detailed Description:
The purpose of the trial is to compare two local anesthetics articaine and bupivacaine for outpatient lower limb surgery
Faster onset and shorter elimination time favours a short-acting local anaesthetic for spinal anesthesia for out-patient lower limb surgery eg knee arthroscopy foot and varices surgery Patients will recover faster and less complications will be expected
Articaine is said to act faster and shorter than a low dose of bupivacaine There are not enough data available to establish that articaine is as safe as and more effective by outpatient lower limb surgery than bupivacaine
Spinal anesthesia with articaine will be compared to spinal anesthesia with bupivacaine in a randomized double blind clinical trial
Endpoints are
onset of sensory and motor block
maximum spread of sensory level
recovery from sensory and motor block
time to micturition
complications
Faster onset and shorter elimination time favours a short-acting local anaesthetic for spinal anesthesia for out-patient lower limb surgery eg knee arthroscopy foot and varices surgery Patients will recover faster and less complications will be expected
Articaine is said to act faster and shorter than a low dose of bupivacaine There are not enough data available to establish that articaine is as safe as and more effective by outpatient lower limb surgery than bupivacaine
Spinal anesthesia with articaine will be compared to spinal anesthesia with bupivacaine in a randomized double blind clinical trial
Endpoints are
onset of sensory and motor block
maximum spread of sensory level
recovery from sensory and motor block
time to micturition
complications
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None