Contusion Wrist or HandNCT02429141
Periarterial Injection Versus Multiple Periveural Injection
A study testing US-guided periarterial techique and US-guided multi-injection technique in people with Contusion Wrist or Hand and Crush Injury Wrist or Hand, run by North American Institute for Continuing Medical Education (NAICE) at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Contusion Wrist or Hand, Crush Injury Wrist or Hand
- What is being tested?
- US-guided periarterial techique and US-guided multi-injection technique
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- US-guided periarterial techique, US-guided multi-injection technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US-guided periarterial techiqueProcedure or surgery
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 techniqueProcedure or surgery
The median, ulnar and radial nerves will be identified by ultrasound. Local anesthetic will be injected adjacent to each nerve
| Study group | Role | What they receive |
|---|---|---|
| US-guided periarterial techique | Experimental | Axillary brachial plexus block by an ultrasound-guided periarterial technique Receives: Procedure: US-guided periarterial techique |
| US-guided multi-injection technique | Experimental | Ultrasound-guided multi-injection perineural technique for axillary brachial plexus Receives: Procedure: US-guided multi-injection technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Block procedure time for the axillary brachial plexus block
Measured: time of the block achievement will be recorded up to 15 minutes
Secondary outcomes (3)
Onset of the block
Measured: outcome measure will be measured up to 30 minutes a
Time to request pain medication
Measured: participants will be followed for 3 days
Block success rate
Measured: participants success or block failure within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contusion Wrist or HandStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- North American Institute for Continuing Medical Education (NAICE)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine Vanderpitt, MD, North American Institute for Continuing Medical Education (NAICE)
- Investigators
- Admir Hadzic, MD, Study director, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429141
- Sponsor's protocol ID
- NAICE-001
- Status last verified
- Aug 2016
- First submitted
- 19 Apr 2015
- Last updated
- 29 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ultrasound Guided Periarterial Injection Technique To Axilary Brachial Plexus Block Versus Perineural Multiple InjectionTechnique
- ClinicalTrials.gov ID
- NCT02429141
- Acronym / sponsor ID
- NAICE-001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- North American Institute for Continuing Medical Education (NAICE)University, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 29 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| US-guided periarterial techique | Experimental | Procedure: US-guided periarterial techiqueAxillary brachial plexus block by an ultrasound-guided periarterial technique |
| US-guided multi-injection technique | Experimental | Procedure: US-guided multi-injection techniqueUltrasound-guided multi-injection perineural technique for axillary brachial plexus |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| US-guided periarterial techiqueThe 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 | Procedure or surgery | US-guided periarterial techique |
| US-guided multi-injection techniqueThe median, ulnar and radial nerves will be identified by ultrasound. Local anesthetic will be injected adjacent to each nerve | Procedure or surgery | US-guided multi-injection technique |
Primary outcome
Block procedure time for the axillary brachial plexus block
Time frame: time of the block achievement will be recorded up to 15 minutes
3 secondary outcomes
Onset of the block
Time frame: outcome measure will be measured up to 30 minutes a
Time to request pain medication
Time frame: participants will be followed for 3 days
Block success rate
Time frame: participants success or block failure within 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Admir Hadzic, MD study director
Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing US-guided periarterial techique and US-guided multi-injection technique in people with Contusion Wrist or Hand and Crush Injury Wrist or Hand, run by North American Institute for Continuing Medical Education (NAICE) at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Block procedure time for the axillary brachial plexus block (time frame: time of the block achievement will be recorded up to 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2016.