Orthopedic DisordersNCT02451813
The Relationship Between Needle Position and Injection Pressure During Femoral Nerve Block
A study testing Apposition of needle bevel against femoral nerve in people with Orthopedic Disorders, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
Trial summary
Recent evidence suggests that injection pressure monitoring may be able to predict needle nerve contact in the brachial plexus nerve block model, but little is known about multifascicular nerves. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Orthopedic Disorders
- What is being tested?
- Apposition of needle bevel against femoral nerve
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Mar 2015
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65
- ASA physical status I-III
- scheduled for lower limb surgery where femoral block is part of intended analgesic plan
Who cannot join
- Contraindication to femoral nerve block (e.g. infection)
- BMI > 35 kg/m2
- inability to communicate postoperative symptoms
- pre-existing neurologic deficits in the operative extremity
- allergy to local anesthetics
- history of opioid dependence
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Luke's-Roosevelt Hospital Center
New York, New York, 10025
About this study
Recent evidence suggests that injection pressure monitoring may be able to predict needle nerve contact in the brachial plexus nerve block model, but little is known about multifascicular nerves. The investigators hypothesize that injection pressure monitoring can reliably predict needle-nerve contact during femoral nerve block.
Read the detailed description
Single center, observational study. Patients scheduled for elective lower limb surgery with femoral nerve block will be recruited. Femoral nerve will be identified using a linear ultrasound transducer. A 22 GA 5 cm nerve block needle will be inserted with bevel downward and advanced to the following conditions:
- Needle tip slightly indenting the fascia iliaca lateral to the femoral nerve
- Needle tip advanced through fascia iliaca
- Needle tip slightly indenting the anterior surface of the femoral nerve
- Needle tip withdrawn 1 mm from nerve.
At each of these conditions, 1 ml of dextrose solution will be injected via an automated pump at 10 ml/min and the spread of injectate observed sonographically. Simultaneously, a blinded observer will measure opening injection pressure using both an electronic and a mechanical transducer. If opening pressure reaches 15 psi, this investigator will halt the injection. In addition, minimum threshold current required to elicit a motor response will be recorded for conditions 3 and 4. Patients will be contacted at 7 days and asked about any adverse effects.
- Conditions
- Orthopedic Disorders
- Being tested
- Apposition of needle bevel against femoral nerve
- Keywords
- opening injection pressure, femoral nerve block, fascia iliaca, ultrasound guided nerve block
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apposition of needle bevel against femoral nerveProcedure or surgery
Indentation of femoral nerve and fascia iliaca by block needle and measurement of opening injection pressure during the controlled injection of 1 ml of dextrose (D5W) solution
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | A 22 GA 5 cm nerve block needle will be advanced to the following conditions:
1. Needle tip slightly indenting the fascia iliaca
2. Needle tip advanced through fascia iliaca
3. Needle tip slightly indenting the anterior surface of the femoral nerve
4. Needle tip withdrawn 1 mm from nerve.
At each of these conditions, 1 ml of dextrose solution will be injected and spread of injectate observed sonographically. A blinded observer will measure injection pressure. If opening pressure reaches 15 psi, this investigator will halt the injection. In addition, minimum threshold current required to elicit a motor response will be recorded for conditions 3 and 4. Receives: Procedure: Apposition of needle bevel against femoral nerve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of high opening injection pressure (15 psi or greater) when needle tip in contact with nerve
Measured: 1 minute
Secondary outcomes (3)
Incidence of high opening injection pressure (15 psi or greater) at other needle locations
Measured: 1 minute
Minimum threshold current to elicit a motor response with needle-nerve contact and needle disengagement
Measured: 1 minute
Incidence of paresthesias
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study startOct 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisordersStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malikah Latmore, MD, Study director, Mount Sinai St. Luke's Mount Sinai Roosevelt Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02451813
- Sponsor's protocol ID
- StLukeNY
- Status last verified
- Mar 2015
- First submitted
- 3 Mar 2015
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Needle Position and Injection Pressure During Femoral Nerve Block
- ClinicalTrials.gov ID
- NCT02451813
- Acronym / sponsor ID
- StLukeNY
- Conditions
- Orthopedic Disorders
- Keywords
- opening injection pressure, femoral nerve block, fascia iliaca, ultrasound guided nerve block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 22 May 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.
Recent evidence suggests that injection pressure monitoring may be able to predict needle nerve contact in the brachial plexus nerve block model, but little is known about multifascicular nerves. The investigators hypothesize that injection pressure monitoring can reliably predict needle-nerve contact during femoral nerve block.
Detailed description
Single center, observational study. Patients scheduled for elective lower limb surgery with femoral nerve block will be recruited. Femoral nerve will be identified using a linear ultrasound transducer. A 22 GA 5 cm nerve block needle will be inserted with bevel downward and advanced to the following conditions:
- Needle tip slightly indenting the fascia iliaca lateral to the femoral nerve
- Needle tip advanced through fascia iliaca
- Needle tip slightly indenting the anterior surface of the femoral nerve
- Needle tip withdrawn 1 mm from nerve.
At each of these conditions, 1 ml of dextrose solution will be injected via an automated pump at 10 ml/min and the spread of injectate observed sonographically. Simultaneously, a blinded observer will measure opening injection pressure using both an electronic and a mechanical transducer. If opening pressure reaches 15 psi, this investigator will halt the injection. In addition, minimum threshold current required to elicit a motor response will be recorded for conditions 3 and 4. Patients will be contacted at 7 days and asked about any adverse effects.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Apposition of needle bevel against femoral nerveA 22 GA 5 cm nerve block needle will be advanced to the following conditions: 1. Needle tip slightly indenting the fascia iliaca 2. Needle tip advanced through fascia iliaca 3. Needle tip slightly indenting the anterior surface of the femoral nerve 4. Needle tip withdrawn 1 mm from nerve. At each of these conditions, 1 ml of dextrose solution will be injected and spread of injectate observed sonographically. A blinded observer will measure injection pressure. If opening pressure reaches 15 psi, this investigator will halt the injection. In addition, minimum threshold current required to elicit a motor response will be recorded for conditions 3 and 4. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-65
- ASA physical status I-III
- scheduled for lower limb surgery where femoral block is part of intended analgesic plan
Key exclusion criteria (6 listed)
- Contraindication to femoral nerve block (e.g. infection)
- BMI > 35 kg/m2
- inability to communicate postoperative symptoms
- pre-existing neurologic deficits in the operative extremity
- allergy to local anesthetics
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 |
|---|---|---|
| Apposition of needle bevel against femoral nerveIndentation of femoral nerve and fascia iliaca by block needle and measurement of opening injection pressure during the controlled injection of 1 ml of dextrose (D5W) solution | Procedure or surgery | Intervention |
Primary outcome
Incidence of high opening injection pressure (15 psi or greater) when needle tip in contact with nerve
Time frame: 1 minute
3 secondary outcomes
Incidence of high opening injection pressure (15 psi or greater) at other needle locations
Time frame: 1 minute
Minimum threshold current to elicit a motor response with needle-nerve contact and needle disengagement
Time frame: 1 minute
Incidence of paresthesias
Time frame: 1 week
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 15 Apr 2016.
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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.
Malikah Latmore, MD study director
Mount Sinai St. Luke's Mount Sinai Roosevelt Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apposition of needle bevel against femoral nerve in people with Orthopedic Disorders, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
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 6 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: finished, as of the sponsor's last update on 15 Apr 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 United States. 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?
Incidence of high opening injection pressure (15 psi or greater) when needle tip in contact with nerve (time frame: 1 minute). 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 Apr 2016.