Ignite Creation Date:
2024-05-06 @ 12:19 AM
Last Modification Date:
2024-10-26 @ 10:47 AM
Study NCT ID:
NCT01542840
Status:
UNKNOWN
Last Update Posted:
2014-03-21
First Post:
2012-02-27
Brief Title:
Onset Time of Nerve Block A Comparison of Two Injection Locations in Patients Having Lower Leg Foot Surgery
Sponsor:
Ochsner Health System
Organization:
Ochsner Health System
Study Overview
Official Title:
Onset Time of Ultrasound-Guided Popliteal Sciatic Nerve Block Comparing Circumferential Injection of Local Anesthetic to Injection That Separates the Nerve in Its Two Components
Status:
UNKNOWN
Status Verified Date:
2014-03
Last Known Status:
NOT_YET_RECRUITING
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 this study is to compare injecting local anesthetic numbing medication in different patterns around a major nerve in the leg Patients who undergo surgery to the lower leg andor foot are usually offered the option of a nerve block to help with pain control after surgery A nerve block involves injecting local anesthetic numbing medicine by a nerve or nerves that provide sensation to the area where surgery will be performed The local anesthetic numbing medication numbs up the area where the surgery is performed and helps decrease the amount of pain felt after surgery The local anesthetic numbing medication can be injected in various patterns by a nerve such as in one spot by a nerve or completely surrounding a nerve The local anesthetic will be either injected around the sciatic nerve or will injected in a way that will split the sciatic nerve into the two component nerves that make it up the tibial and sciatic and surrounds each nerve
The hypothesis is that subjects in the group that local anesthetic is injected in a pattern that separates the sciatic nerve into the two component nerves may have a faster onset time of regional anesthesia and block success than subjects in the group that have the local anesthetic injected at around the nerve
The hypothesis is that subjects in the group that local anesthetic is injected in a pattern that separates the sciatic nerve into the two component nerves may have a faster onset time of regional anesthesia and block success than subjects in the group that have the local anesthetic injected at around the nerve
Detailed Description:
After the consent form is signed subjects will be randomly assigned like the flip of a coin to either receive the local anesthestic numbing medication around the sciatic nerve or in a pattern that separates the sciatic nerve into the two component nerves that make it up the tibial and sciatic and surrounds each nerve
Before the nerve block is performed the movement and sensation in the subjects foot will be checked to make sure it is normal They will be asked to move their foot up and down Using a blunt safety needle their foot will be gently touched in different places to see if they can feel sharp sensations
The amount of relaxation medication before the block will be recorded The local anesthetic numbing medication will be injected in the pattern subjects were randomly assigned The time it takes from the moment they are asked to say their name and birthday until they cannot move or feel their foot will be recorded
Five minutes from the time the injection is complete subjects will be asked to move their foot up and down Also their foot will be gently touched in different places with a blunt safety needle to see if they can still feel sharp sensations Subjects will be asked to do this every five minutes until they cannot feel any sensation in their foot or if thirty minutes pass
A member of the study team will contact subjects by telephone in about a week to see if they have any pain numbness andor weakness in their legfoot
Before the nerve block is performed the movement and sensation in the subjects foot will be checked to make sure it is normal They will be asked to move their foot up and down Using a blunt safety needle their foot will be gently touched in different places to see if they can feel sharp sensations
The amount of relaxation medication before the block will be recorded The local anesthetic numbing medication will be injected in the pattern subjects were randomly assigned The time it takes from the moment they are asked to say their name and birthday until they cannot move or feel their foot will be recorded
Five minutes from the time the injection is complete subjects will be asked to move their foot up and down Also their foot will be gently touched in different places with a blunt safety needle to see if they can still feel sharp sensations Subjects will be asked to do this every five minutes until they cannot feel any sensation in their foot or if thirty minutes pass
A member of the study team will contact subjects by telephone in about a week to see if they have any pain numbness andor weakness in their legfoot
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