Onset Time of Nerve Block: A Comparison of Two Injection Locations in Patients Having Lower Leg/ Foot Surgery
|ClinicalTrials.gov Identifier: NCT01542840|
Recruitment Status : Unknown
Verified March 2014 by Kristie Osteen, Ochsner Health System.
Recruitment status was: Not yet recruiting
First Posted : March 2, 2012
Last Update Posted : March 21, 2014
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 and/or 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.
|Condition or disease|
|Strain of Muscle and/or Tendon of Lower Leg Fracture of Lower Leg Crushing Injury of Lower Leg Fracture Malunion - Ankle and/or Foot Disorder of Joint of Ankle and/or Foot Complete Tear, Ankle and/or Foot Ligament Pathological Fracture - Ankle and/or Foot Loose Body in Joint of Ankle and/or Foot|
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 subject's 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, and/or weakness in their leg/foot.
|Study Type :||Observational|
|Estimated Enrollment :||76 participants|
|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|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||March 2016|
|Estimated Study Completion Date :||March 2016|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01542840
|United States, Louisiana|
|Ochsner Clinic Foundation||Not yet recruiting|
|New Orleans, Louisiana, United States, 70121|
|Contact: Kristie D Osteen, MD 504-842-3755 firstname.lastname@example.org|
|Principal Investigator: Kristie D Osteen, MD|
|Principal Investigator:||Kristie D Osteen, MD||Ochsner Health System|