ED95 of Lidocaine 1.0% for Filling the Adductor Canal

Study Overview
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Brief Summary
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The aim of this prospective dose finding study is to estimate the minimal effective volume (ED95) for lidocaine 1.0% for filling the adductor canal when placing an adductor canal block. We will apply the Continual Reassessment Method (CRM) for estimating the ED95 and use an MRI scan to evaluate the main objective and ensure spread to the distal part of the adductor canal.

Official Title
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An Estimate of the ED95 of Lidocaine 1.0% for Filling the Adductor Canal When Placing an Adductor Canal Block in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Procedure: Adductor canal block with lidocaine 1%
* Drug: Lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-30 years Men American Society of Anesthesiologists' class 1 Body Mass Index 18-25 Exclusion Criteria: Allergy to study medication Earlier trauma or surgery to the lower limb Diabetes Mellitus - Contraindications to MRI

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACB with 30 ml lidocaine 1%<br>Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study. Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml. | Procedure: Adductor canal block with lidocaine 1%<br>* US-guided adductor canal block<br>Drug: Lidocaine<br> <br> |
| Experimental: ACB with 25 ml lidocaine 1%<br>Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study. Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml. | Procedure: Adductor canal block with lidocaine 1%<br>* US-guided adductor canal block<br>Drug: Lidocaine<br> <br> |
| Experimental: ACB with 20 ml lidocaine 1%<br>Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study. Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml. | Procedure: Adductor canal block with lidocaine 1%<br>* US-guided adductor canal block<br>Drug: Lidocaine<br> <br> |
| Experimental: ACB with 15 ml lidocaine 1%<br>Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study. Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml. | Procedure: Adductor canal block with lidocaine 1%<br>* US-guided adductor canal block<br>Drug: Lidocaine<br> <br> |
| Experimental: ACB with 10 ml lidocaine 1%<br>Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study. Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml. | Procedure: Adductor canal block with lidocaine 1%<br>* US-guided adductor canal block<br>Drug: Lidocaine<br> <br> |
| Experimental: ACB with 5 ml lidocaine 1%<br>Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study. Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml. | Procedure: Adductor canal block with lidocaine 1%<br>* US-guided adductor canal block<br>Drug: Lidocaine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the ED 95 for the volume needed to fill the adductor canal distally. | This will be evaluated as a binary outcome using MRI; where the adductor canal is considered to be filled if the lidocaine injectate can be identified inside the canal in the first slice distally to the insertion of the adductor longus muscle on femur. | MRI performed 15 minutes post block | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the effect of volume on proximal spread to the femoral triangle | Evaluated as a binary outcome using MRI | MRI performed 15 minutes post block | 
| Quadriceps muscle strength | To investigate the effect of volume on quadriceps muscle strength, assessed as maximum voluntary isometric contraction (MVIC) and evaluated as a binary outcome (reduction by more or less than 25%). | 1 hour post block | 
| Pin prick test | To investigate the effect of volume on sensory block assessed by pin-prick in the saphenous innervation area and in the popliteal fossa. | 1 hour post block | 
| Temperature discrimination test | To investigate the effect of volume on sensory block assessed by cold sensation using alchohol swabs, in the saphenous innervation area and in the popliteal fossa. | 1 hour post block | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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volunteers, MRI, adductor canal block, US-guided peripheral nerve block, lower limb