Anesthesia, LocalPhase 4NCT07444827
Targeted Nerve Injection to the Knee (Nerve to Vastus Medialis): Comparing Two Adductor Canal Block Approaches
A Phase 4 study testing Traditional adductor canal block, NVM (nerve to vastus medialis) targeted adductor canal block and Chloroprocaine Injection in people with Anesthesia, Local, run by Duke University.
Trial summary
This randomized, double-blinded volunteer study compares two ways of performing the adductor canal (AC) nerve block at the mid-thigh to see which approach more reliably numbs the anteromedial knee. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- Traditional adductor canal block, NVM (nerve to vastus medialis) targeted adductor canal block and Chloroprocaine Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 1 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Able to provide written informed consent
- Able and willing to comply with study procedures and ~6-hour visit
- American Society of Anesthesiologists (ASA) Physical Status 1 or 2
- Weight >70 kg
Who cannot join
- BMI >35 kg/m²
- Use of analgesics within 24 hours before the procedure
- History of thigh trauma or surgery
- Pregnant or planning pregnancy
- Lower extremity deformities/tattoos interfering with block performance
- Systemic neuromuscular disease
- Contraindications to regional anesthesia (e.g., infection, allergy, challenging sonoanatomy)
- Other health conditions that would affect safe participation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Study of Targeted Injection of Nerves to the Knee-A Volunteer Trial Evaluating Nerve to Vastus Medialis
This randomized, double-blinded volunteer study compares two ways of performing the adductor canal (AC) nerve block at the mid-thigh to see which approach more reliably numbs the anteromedial knee. One approach is the traditional AC block placed near the saphenous nerve; the other separately targets the nerve to vastus medialis (NVM) in addition to the saphenous nerve. Healthy adult participants receive both blocks in one visit (one on each leg), with the order randomized. The primary outcome is change in quadriceps strength (a proxy for vastus medialis anesthesia) measured by load-cell dynamometry. Secondary outcomes include cutaneous sensory mapping (pinprick and cold) and the percentage of a standardized, marked knee-incision line covered by sensory block. The study uses ultrasound guidance and a standard dose of chloroprocaine, with routine monitoring to minimize risks.
- Conditions
- Anesthesia, Local
- Being tested
- Traditional adductor canal block, NVM (nerve to vastus medialis) targeted adductor canal block, Chloroprocaine Injection
- Keywords
- Adductor canal block, Nerve to vastus medialis, Chloroprocaine, Knee joint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional adductor canal blockProcedure or surgery
Ultrasound-guided injection adjacent to the saphenous nerve; 20 mL of 2% chloroprocaine.
NVM (nerve to vastus medialis) targeted adductor canal blockProcedure or surgery
Ultrasound-guided injection; 10 mL 2% chloroprocaine at the NVM (confirmed by nerve stimulation), plus 10 mL at the saphenous nerve.
Chloroprocaine InjectionDrug
2% chloroprocaine
| Study group | Role | What they receive |
|---|---|---|
| Traditional adductor canal block | Active comparator | 20 mL of 2% chloroprocaine deposited adjacent to the saphenous nerve under ultrasound guidance. Receives: Procedure: Traditional adductor canal block; Drug: Chloroprocaine Injection |
| NVM (nerve to vastus medialis) targeted adductor canal block | Experimental | 10 mL of 2% chloroprocaine by the NVM (confirmed with nerve stimulation), plus 10 mL by the saphenous nerve (total 20 mL), under ultrasound guidance. Receives: Procedure: NVM (nerve to vastus medialis) targeted adductor canal block; Drug: Chloroprocaine Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps strength as measured by load cell dynamometer
Load cell dynamometers are highly accurate portable electronic devices used to measure isometric muscle strength.
Measured: Day 1
Secondary outcomes (1)
Percentage of hypothetical incision covered
An unblinded anesthesiologist will mark the mock total knee arthroplasty and the length of the hypothetical incision that has diminished sensation to pinprick will be determined.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Mendelson, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444827
- Sponsor's protocol ID
- PRO00119256
- Status last verified
- Feb 2026
- First submitted
- 25 Feb 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Targeted Injection of Nerves to the Knee-A Volunteer Trial Evaluating Nerve to Vastus Medialis
- ClinicalTrials.gov ID
- NCT07444827
- Acronym / sponsor ID
- PRO00119256
- Conditions
- Anesthesia, Local
- Keywords
- Adductor canal block, Nerve to vastus medialis, Chloroprocaine, Knee joint
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 3 Mar 2026 (actual)
- 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.
This randomized, double-blinded volunteer study compares two ways of performing the adductor canal (AC) nerve block at the mid-thigh to see which approach more reliably numbs the anteromedial knee. One approach is the traditional AC block placed near the saphenous nerve; the other separately targets the nerve to vastus medialis (NVM) in addition to the saphenous nerve. Healthy adult participants receive both blocks in one visit (one on each leg), with the order randomized. The primary outcome is change in quadriceps strength (a proxy for vastus medialis anesthesia) measured by load-cell dynamometry. Secondary outcomes include cutaneous sensory mapping (pinprick and cold) and the percentage of a standardized, marked knee-incision line covered by sensory block. The study uses ultrasound guidance and a standard dose of chloroprocaine, with routine monitoring to minimize risks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional adductor canal block | Active comparator | Procedure: Traditional adductor canal block, Drug: Chloroprocaine Injection20 mL of 2% chloroprocaine deposited adjacent to the saphenous nerve under ultrasound guidance. |
| NVM (nerve to vastus medialis) targeted adductor canal block | Experimental | Procedure: NVM (nerve to vastus medialis) targeted adductor canal block, Drug: Chloroprocaine Injection10 mL of 2% chloroprocaine by the NVM (confirmed with nerve stimulation), plus 10 mL by the saphenous nerve (total 20 mL), under ultrasound guidance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- Able to provide written informed consent
- Able and willing to comply with study procedures and ~6-hour visit
- American Society of Anesthesiologists (ASA) Physical Status 1 or 2
- Weight >70 kg
Key exclusion criteria (8 listed)
- BMI >35 kg/m²
- Use of analgesics within 24 hours before the procedure
- History of thigh trauma or surgery
- Pregnant or planning pregnancy
- Lower extremity deformities/tattoos interfering with block performance
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 |
|---|---|---|
| Traditional adductor canal blockUltrasound-guided injection adjacent to the saphenous nerve; 20 mL of 2% chloroprocaine. | Procedure or surgery | Traditional adductor canal block |
| NVM (nerve to vastus medialis) targeted adductor canal blockUltrasound-guided injection; 10 mL 2% chloroprocaine at the NVM (confirmed by nerve stimulation), plus 10 mL at the saphenous nerve. | Procedure or surgery | NVM (nerve to vastus medialis) targeted adductor canal block |
| Chloroprocaine Injection2% chloroprocaine | Drug | NVM (nerve to vastus medialis) targeted adductor canal block, Traditional adductor canal block |
Primary outcome
Quadriceps strength as measured by load cell dynamometer
Time frame: Day 1
Load cell dynamometers are highly accurate portable electronic devices used to measure isometric muscle strength.
1 secondary outcome
Percentage of hypothetical incision covered
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Brian Mendelson principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Traditional adductor canal block, NVM (nerve to vastus medialis) targeted adductor canal block and Chloroprocaine Injection in people with Anesthesia, Local, run by Duke University.
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 5 inclusion and 8 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: opening soon, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashley Burke ((919) 681-2849, ashley.burke@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quadriceps strength as measured by load cell dynamometer (time frame: Day 1). 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 27 Aug 2026.