Targeted Nerve Injection to the Knee (Nerve to Vastus Medialis): Comparing Two Adductor Canal Block Approaches
Study of Targeted Injection of Nerves to the Knee-A Volunteer Trial Evaluating Nerve to Vastus Medialis
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 4
Contacts and Locations
Study Contact
Study Contact
- Name: Ashley Burke
- Phone Number: (919) 681-2849
- Email: ashley.burke@duke.edu
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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
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
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
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Brian Mendelson, Duke University
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- PRO00119256
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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