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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
North American Institute for Continuing Medical Education (NAICE)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Contusion Wrist or Hand

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  1. Inclusion criteria:

    - Patients (ASA physical status I-III) scheduled to undergo hand or wrist surgery under axillary brachial plexus block

  2. 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

First Posted
April 19, 2015
Last Updated
August 26, 2016
Sponsor
North American Institute for Continuing Medical Education (NAICE)
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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

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Periarterial Injection Versus Multiple Periveural Injection

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