Periarterial Injection Versus Multiple Periveural Injection
Primary Purpose
Contusion Wrist or Hand, Crush Injury Wrist or Hand
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
US-guided periarterial techique
US-guided multi-injection technique
Sponsored by
About this trial
This is an interventional treatment trial for Contusion Wrist or Hand
Eligibility Criteria
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
Sites / Locations
- Department of Anesthesiology Ziekenhuis Oost-Limburg
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
US-guided periarterial techique
US-guided multi-injection technique
Arm Description
Axillary brachial plexus block by an ultrasound-guided periarterial technique
Ultrasound-guided multi-injection perineural technique for axillary brachial plexus
Outcomes
Primary Outcome Measures
Block procedure time for the axillary brachial plexus block
Secondary Outcome Measures
Onset of the block
Time to request pain medication
Block success rate
Full Information
NCT ID
NCT02429141
First Posted
April 19, 2015
Last Updated
August 26, 2016
Sponsor
North American Institute for Continuing Medical Education (NAICE)
1. Study Identification
Unique Protocol Identification Number
NCT02429141
Brief Title
Periarterial Injection Versus Multiple Periveural Injection
Official Title
The Ultrasound Guided Periarterial Injection Technique To Axilary Brachial Plexus Block Versus Perineural Multiple InjectionTechnique
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
North American Institute for Continuing Medical Education (NAICE)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contusion Wrist or Hand, Crush Injury Wrist or Hand
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
US-guided periarterial techique
Arm Type
Experimental
Arm Description
Axillary brachial plexus block by an ultrasound-guided periarterial technique
Arm Title
US-guided multi-injection technique
Arm Type
Experimental
Arm Description
Ultrasound-guided multi-injection perineural technique for axillary brachial plexus
Intervention Type
Procedure
Intervention Name(s)
US-guided periarterial techique
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
US-guided multi-injection technique
Intervention Description
The median, ulnar and radial nerves will be identified by ultrasound. Local anesthetic will be injected adjacent to each nerve
Primary Outcome Measure Information:
Title
Block procedure time for the axillary brachial plexus block
Time Frame
time of the block achievement will be recorded up to 15 minutes
Secondary Outcome Measure Information:
Title
Onset of the block
Time Frame
outcome measure will be measured up to 30 minutes a
Title
Time to request pain medication
Time Frame
participants will be followed for 3 days
Title
Block success rate
Time Frame
participants success or block failure within 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Admir Hadzic, MD
Organizational Affiliation
Director
Official's Role
Study Director
Facility Information:
Facility Name
Department of Anesthesiology Ziekenhuis Oost-Limburg
City
Genk
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Periarterial Injection Versus Multiple Periveural Injection
We'll reach out to this number within 24 hrs