Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00221884
Status:
COMPLETED
Last Update Posted:
2008-12-05
First Post:
2005-09-20
Brief Title:
Use of Ultrasound in Upper Extremity Blocks
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Does Ultrasound Guidance Improve the Success of Brachial Plexus Block A Prospective Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2005-09
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:
Many patients undergoing surgery on their hand receive a form of anesthetic called axillary brachial plexus block This involves the injection of local anesthetic freezing medication around the nerves that supply the upper limb which are located in the arm pit The technique currently used by physicians performing this procedure is far from perfect and in up to 1 of every 5 patients it does not work well enough to allow surgery and a different form of anesthetic may need to be used
In an attempt to improve these results we have recently developed a new technique using ultrasound imaging to see the nerves prior to giving the injection Our initial results are very promising implying that this may be a highly successful and safe approach The purpose of this study is to determine if this technique is indeed more successful In order to do that we will ask 110 patients for their participation They will be divided in two groups at random One group will receive the standard technique transarterial using a small needle to find the artery that is close to the nerves The other group will receive the injection after identifying the nerves with ultrasound imaging They will all receive the same type of medication and they will be tested every 5 minutes for half an hour to determine if the block has been successful according to pre-established criteria Their pain control will be assessed after the surgery and they will be called 24 hours and 1 week after the surgery to assess their recovery and rule out any possible complications
In an attempt to improve these results we have recently developed a new technique using ultrasound imaging to see the nerves prior to giving the injection Our initial results are very promising implying that this may be a highly successful and safe approach The purpose of this study is to determine if this technique is indeed more successful In order to do that we will ask 110 patients for their participation They will be divided in two groups at random One group will receive the standard technique transarterial using a small needle to find the artery that is close to the nerves The other group will receive the injection after identifying the nerves with ultrasound imaging They will all receive the same type of medication and they will be tested every 5 minutes for half an hour to determine if the block has been successful according to pre-established criteria Their pain control will be assessed after the surgery and they will be called 24 hours and 1 week after the surgery to assess their recovery and rule out any possible complications
Detailed Description:
Ultrasonography has been used successfully to define the anatomy of the brachial plexus in the interscalene supraclavicular and axillary regions This is a widely available technology it is non-invasive portable less expensive than other imaging modalities and allows for real time imaging simultaneously with the block procedure
There are some recent case reports and small case series describing the use of ultrasound to image the brachial plexus and to guide brachial plexus blockade 161718 We have used ultrasound imaging to succesfully identify the brachial plexus and guide needle localization and nerve stimulation in 15 volunteers 19 In these healthy volunteers we were able to identify the brachial plexus in every subject at four different anatomical levels interscalene supraclavicular axillary and mid-humeral see figures Needle localization and nerve stimulation were also successful in every case Moreover preliminary data from an ongoing series at our institution shows that when ultrasound guidance is used supraclavicular brachial plexus block can be performed with a high success rate 9720
However whether ultrasound guidance truly improves success rates when compared to more traditional techniques is still unknown There has been no randomized controlled trial published to date addressing this question
There are some recent case reports and small case series describing the use of ultrasound to image the brachial plexus and to guide brachial plexus blockade 161718 We have used ultrasound imaging to succesfully identify the brachial plexus and guide needle localization and nerve stimulation in 15 volunteers 19 In these healthy volunteers we were able to identify the brachial plexus in every subject at four different anatomical levels interscalene supraclavicular axillary and mid-humeral see figures Needle localization and nerve stimulation were also successful in every case Moreover preliminary data from an ongoing series at our institution shows that when ultrasound guidance is used supraclavicular brachial plexus block can be performed with a high success rate 9720
However whether ultrasound guidance truly improves success rates when compared to more traditional techniques is still unknown There has been no randomized controlled trial published to date addressing this question
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