Peripheral Nerve InjuryNCT01554722
Needle Nerve Contact in Ultrasound Guided Femoral Block
A study testing Needle placement in people with Peripheral Nerve Injury, run by Hospital Clinic of Barcelona at 2 sites in 2 countries.
Trial summary
Ultrasound-guided femoral nerve block is a common regional anesthesia technique. The optimal method of needle guidance (in-plane versus out-of-plane) with regards to the block efficacy and avoidance of needle-nerve contact has not been established. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Nerve Injury
- What is being tested?
- Needle placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2011to Mar 2012
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA physical status 1-3 patients
- Diagnosis of trochanteric or cervical hip fracture
- Hip replacement under spinal anesthesia
Who cannot join
- Patients under the age of 65 years or over the age of 90 years
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
St Luke'S Roosevelt Hospital, Columbia University
New York, New York, 10025
Admir Hadzic, PROF.DR
Spain1 site, 1 recruiting
- Recruiting
University of Barcelona
Barcelona
Xavier Sala-Blanch, MD, 0034932275558, Xavier Sala-Blanch <xavi.sala.blanch@gmail.com>
Ana Ruiz, MD
About this study
Official title: Incidence of Intraneural Needle Insertion in Ultrasound Guided Femoral Block: Out of Plane Versus in Plane Approach
Ultrasound-guided femoral nerve block is a common regional anesthesia technique. The optimal method of needle guidance (in-plane versus out-of-plane) with regards to the block efficacy and avoidance of needle-nerve contact has not been established. In this study the investigators tests the hypothesis that the incidence of needle-nerve contact is higher with the needle insertion in an out-of-plane than with the in-plane approach.
Read the detailed description
Fourty-four patients with hip fracture (American Society of Anesthesiologists physical status 1-3) are being randomized to receive the femoral block with an out-of-plane (needle inserted at a 45°-60° angle 1 cm caudal to the midpoint of the ultrasound probe just above the femoral nerve) or an in-plane technique (needle inserted 0.5 cm from the side of the probe lateral to the femoral nerve). The data collected includes the depth of needle insertion at the endpoint before injection, response to nerve stimulation, distribution of the injected volume in relation to the nerve (anterior vs posterior, the latter indicating impalement), block efficacy at 20 minutes and 24 hours, and any signs of nerve injury).
- Conditions
- Peripheral Nerve Injury
- Being tested
- Needle placement
- Keywords
- Ultrasound guidance, Femoral nerve block, Needle placement, Intraneural needle insertion
- Medical subject headings
- Peripheral Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Needle placementProcedure or surgery
In plane versus out of plane needle placement techniques
| Study group | Role | What they receive |
|---|---|---|
| in plane needle placement | Experimental | Not described Receives: Procedure: Needle placement |
| out of plane needle placement | Experimental | Not described Receives: Procedure: Needle placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of intraneural needle insertion in ultrasound-guided femoral block: out-of-plane versus in-plane approach
The incidence of needle-nerve contact is higher with the out-of-plane approach (inserting the needle into the fascia at the midpoint over the femoral nerve)needle-nerve contact than with the in-plane approach (inserting the needle lateral to the femoral nerve).
Measured: 4 months
Secondary outcomes (1)
Number of Participants with femoral block success in ultrasound-guided femoral block: out-of-plane versus in-plane approach.
The efficacy of the out-of-plane approach (inserting the needle into the fascia at the midpoint over the femoral nerve)needle-nerve contact and the in-plane approach (inserting the needle lateral to the femoral nerve).
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startNov 2011
- Primary completionMar 2012 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nerve InjuryStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Ruiz, Hospital Clinic of Barcelona
- Investigators
- Xavier Sala-Blanch, MD, Principal investigator, University Clinic BarcelonaAna Ruiz, MD, Principal investigator, University of BarcelonaJulia Martinez-Ocon, MD, Study chair, University of BarcelonaMaria J Carretero, MD, Study chair, University of BarcelonaGerard Sánchez-Etayo, MD, Study chair, University of BarcelonaAdmir Hadzic, Prof Dr, Study director, Columbia University St Luke's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01554722
- Sponsor's protocol ID
- R6345
- Status last verified
- Mar 2012
- First submitted
- 27 Feb 2012
- Last updated
- 15 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Intraneural Needle Insertion in Ultrasound Guided Femoral Block: Out of Plane Versus in Plane Approach
- ClinicalTrials.gov ID
- NCT01554722
- Acronym / sponsor ID
- R6345
- Conditions
- Peripheral Nerve Injury
- Keywords
- Ultrasound guidance, Femoral nerve block, Needle placement, Intraneural needle insertion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 15 Mar 2012 (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.
Ultrasound-guided femoral nerve block is a common regional anesthesia technique. The optimal method of needle guidance (in-plane versus out-of-plane) with regards to the block efficacy and avoidance of needle-nerve contact has not been established. In this study the investigators tests the hypothesis that the incidence of needle-nerve contact is higher with the needle insertion in an out-of-plane than with the in-plane approach.
Detailed description
Fourty-four patients with hip fracture (American Society of Anesthesiologists physical status 1-3) are being randomized to receive the femoral block with an out-of-plane (needle inserted at a 45°-60° angle 1 cm caudal to the midpoint of the ultrasound probe just above the femoral nerve) or an in-plane technique (needle inserted 0.5 cm from the side of the probe lateral to the femoral nerve). The data collected includes the depth of needle insertion at the endpoint before injection, response to nerve stimulation, distribution of the injected volume in relation to the nerve (anterior vs posterior, the latter indicating impalement), block efficacy at 20 minutes and 24 hours, and any signs of nerve injury).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| in plane needle placement | Experimental | Procedure: Needle placement |
| out of plane needle placement | Experimental | Procedure: Needle placement |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA physical status 1-3 patients
- Diagnosis of trochanteric or cervical hip fracture
- Hip replacement under spinal anesthesia
Key exclusion criteria (1 listed)
- Patients under the age of 65 years or over the age of 90 years
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 |
|---|---|---|
| Needle placementIn plane versus out of plane needle placement techniques | Procedure or surgery | in plane needle placement, out of plane needle placement |
Primary outcome
Number of intraneural needle insertion in ultrasound-guided femoral block: out-of-plane versus in-plane approach
Time frame: 4 months
The incidence of needle-nerve contact is higher with the out-of-plane approach (inserting the needle into the fascia at the midpoint over the femoral nerve)needle-nerve contact than with the in-plane approach (inserting the needle lateral to the femoral nerve).
1 secondary outcome
Number of Participants with femoral block success in ultrasound-guided femoral block: out-of-plane versus in-plane approach.
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2012.
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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.
Xavier Sala-Blanch, MD principal investigator
University Clinic Barcelona
Ana Ruiz, MD principal investigator
University of Barcelona
Julia Martinez-Ocon, MD study chair
University of Barcelona
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Needle placement in people with Peripheral Nerve Injury, run by Hospital Clinic of Barcelona at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 15 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana Ruiz, MD (0034932275558, anaruiz@clinic.ub.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of intraneural needle insertion in ultrasound-guided femoral block: out-of-plane versus in-plane approach (time frame: 4 months). 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 15 Mar 2012.