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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02429141
Other study ID # NAICE-001
Secondary ID
Status Completed
Phase N/A
First received April 19, 2015
Last updated August 26, 2016
Start date January 2015
Est. completion date June 2016

Study information

Verified date August 2016
Source North American Institute for Continuing Medical Education (NAICE)
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date June 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Procedure:
US-guided periarterial techique
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
US-guided multi-injection technique
The median, ulnar and radial nerves will be identified by ultrasound. Local anesthetic will be injected adjacent to each nerve

Locations

Country Name City State
Belgium Department of Anesthesiology Ziekenhuis Oost-Limburg Genk

Sponsors (1)

Lead Sponsor Collaborator
North American Institute for Continuing Medical Education (NAICE)

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Block procedure time for the axillary brachial plexus block time of the block achievement will be recorded up to 15 minutes No
Secondary Onset of the block outcome measure will be measured up to 30 minutes a No
Secondary Time to request pain medication participants will be followed for 3 days No
Secondary Block success rate participants success or block failure within 24 hours No