ED95 of Lidocaine 1.0% for Filling the Adductor Canal
- Conditions
- Healthy
- Interventions
- Procedure: Adductor canal block with lidocaine 1%
- Registration Number
- NCT02033356
- Lead Sponsor
- Rigshospitalet, Denmark
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 40
- 18-30 years
- Men
- American Society of Anesthesiologists' class 1
- Body Mass Index 18-25
- Allergy to study medication
- Earlier trauma or surgery to the lower limb
- Diabetes Mellitus - Contraindications to MRI
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ACB with 20 ml lidocaine 1% Adductor canal block with lidocaine 1% 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. ACB with 20 ml lidocaine 1% Lidocaine 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. ACB with 15 ml lidocaine 1% Adductor canal block with lidocaine 1% 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. ACB with 10 ml lidocaine 1% Adductor canal block with lidocaine 1% 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. ACB with 30 ml lidocaine 1% Adductor canal block with lidocaine 1% 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. ACB with 25 ml lidocaine 1% Adductor canal block with lidocaine 1% 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. ACB with 10 ml lidocaine 1% Lidocaine 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. ACB with 5 ml lidocaine 1% Lidocaine 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. ACB with 5 ml lidocaine 1% Adductor canal block with lidocaine 1% 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. ACB with 30 ml lidocaine 1% Lidocaine 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. ACB with 25 ml lidocaine 1% Lidocaine 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. ACB with 15 ml lidocaine 1% Lidocaine 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Aleris-Hamlet Hospitals Copenhagen
🇩🇰Søborg, Denmark