An estimate of the lowest volume needed to fill the adductor canal when placing an adductor canal block in healthy volunteers
Phase 1
- Conditions
- Healthy volunteers (treatment intended for postoperative pain relief in patients after knee surgery)MedDRA version: 14.1Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 100000004865Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2013-004462-33-DK
- Lead Sponsor
- Professor Jørgen B. Dahl
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
Men
Age 18-30 years
ASA 1
Body Mass Index 18-25
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Allergy to study mediacation
Earlier trauma or surgery to the lower limb
Diabetes Mellitus
Contraindications to MRI
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The aim of this prospective dose finding study is to estimate the minmal effective volume (ED95) for lidocaine 1.0% for filling the adductor canal when placing an adductor canal block. We will apply the Continual Reassesment 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. <br>;Secondary Objective: Secondary objectives are to investigate the effect on volume on spread to the femoral tiangle, muscle strength and sensory block.;Primary end point(s): 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. ;Timepoint(s) of evaluation of this end point: Evaluated using MRI performed 15 minutes post block
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • To investigate the effect of volume on proximal spread to the femoral triangle, evaluated as a binary outcome using MRI. <br>• To investigate the effect of volume on quadriceps muscle strength, assessed as maximum voluntary isometric contraction (MVIC) 1 hour post block and evaluated as a binary outcome (redcution by more or less than 25%).<br>• To investigate the effect of volume on sensory block assessed by pin-prick in the saphenous innervation area and in the popliteal fossa.<br>• 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.<br>;Timepoint(s) of evaluation of this end point: Proximal spread will be avaluated using MRI performed at 15 minutes post block.<br>Other secondary endpoints will be assessed at 1 h post block.