- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02429141
Periarterial Injection Versus Multiple Periveural Injection
August 26, 2016 updated by: Catherine Vanderpitt, MD, North American Institute for Continuing Medical Education (NAICE)
The Ultrasound Guided Periarterial Injection Technique To Axilary Brachial Plexus Block Versus Perineural Multiple InjectionTechnique
In the transarterial technique for axillary brachial plexus block, the axillary artery is intentionally punctured to indicate placement of the needle within the neurovascular sheath; local anesthetic is then injected deep and superficial to the axillary artery.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
To lessen the risk for hematoma and intravascular injection, several modifications, such as the multi-injection perineural technique, have become popular.
These techniques require a high degree of technical skill and multiple needle passes, and also carry potential for injury.
In this study, the investigators will compare an ultrasound-guided equivalent of the transarterial technique (periarterial injections) to a commonly used multi-injection perineural technique.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Genk, Belgium
- Department of Anesthesiology Ziekenhuis Oost-Limburg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- Patients (ASA physical status I-III) scheduled to undergo hand or wrist surgery under axillary brachial plexus block
Exclusion criteria:
- Patients with pre-existing neuropathy
- Patients with allergy to local anesthetics
- Patients with prior surgery in the ipsilateral axilla
- Pregnant patients
- Patients with difficulties in communication
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: US-guided periarterial techique
Axillary brachial plexus block by an ultrasound-guided periarterial technique
|
The needle will be inserted in the axillary fossa in-plane (cranial to caudal) close to the intersection of the pectoralis and biceps muscles.
Two separate injections of local anesthetic will be made deep and superficial to the axillary artery
|
Experimental: US-guided multi-injection technique
Ultrasound-guided multi-injection perineural technique for axillary brachial plexus
|
The median, ulnar and radial nerves will be identified by ultrasound.
Local anesthetic will be injected adjacent to each nerve
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Block procedure time for the axillary brachial plexus block
Time Frame: time of the block achievement will be recorded up to 15 minutes
|
time of the block achievement will be recorded up to 15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Onset of the block
Time Frame: outcome measure will be measured up to 30 minutes a
|
outcome measure will be measured up to 30 minutes a
|
Time to request pain medication
Time Frame: participants will be followed for 3 days
|
participants will be followed for 3 days
|
Block success rate
Time Frame: participants success or block failure within 24 hours
|
participants success or block failure within 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Admir Hadzic, MD, Director
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
April 19, 2015
First Submitted That Met QC Criteria
April 28, 2015
First Posted (Estimate)
April 29, 2015
Study Record Updates
Last Update Posted (Estimate)
August 29, 2016
Last Update Submitted That Met QC Criteria
August 26, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NAICE-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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