Healthy
Conditions
Keywords
adductor canal block, volunteers, US-guided peripheral nerve block, lower limb, MRI
Brief summary
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.
Interventions
PROCEDUREAdductor canal block with lidocaine 1%
US-guided adductor canal block
DRUGLidocaine
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 30 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To estimate the ED 95 for the volume needed to fill the adductor canal distally. | MRI performed 15 minutes post block | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To investigate the effect of volume on proximal spread to the femoral triangle | MRI performed 15 minutes post block | Evaluated as a binary outcome using MRI |
| Quadriceps muscle strength | 1 hour post block | 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%). |
| Pin prick test | 1 hour post block | To investigate the effect of volume on sensory block assessed by pin-prick in the saphenous innervation area and in the popliteal fossa. |
| Temperature discrimination test | 1 hour post block | 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. |
Countries
Denmark
Outcome results
None listed