- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07444827
Targeted Nerve Injection to the Knee (Nerve to Vastus Medialis): Comparing Two Adductor Canal Block Approaches
February 25, 2026 updated by: Duke University
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.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
25
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ashley Burke
- Phone Number: (919) 681-2849
- Email: ashley.burke@duke.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Traditional adductor canal block
20 mL of 2% chloroprocaine deposited adjacent to the saphenous nerve under ultrasound guidance.
|
Ultrasound-guided injection adjacent to the saphenous nerve; 20 mL of 2% chloroprocaine.
2% chloroprocaine
|
|
Experimental: NVM (nerve to vastus medialis) targeted adductor canal block
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.
|
2% chloroprocaine
Ultrasound-guided injection; 10 mL 2% chloroprocaine at the NVM (confirmed by nerve stimulation), plus 10 mL at the saphenous nerve.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of hypothetical incision covered
Time Frame: Day 1
|
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.
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Brian Mendelson, Duke University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
December 1, 2027
Study Registration Dates
First Submitted
February 25, 2026
First Submitted That Met QC Criteria
February 25, 2026
First Posted (Actual)
March 3, 2026
Study Record Updates
Last Update Posted (Actual)
March 3, 2026
Last Update Submitted That Met QC Criteria
February 25, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO00119256
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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