A comparison of the efficacy of the Adductor-Canal-Blockade vs. the femoral nerve block on muscle strength and mobilization in healthy volunteers: a randomized study
Phase 1
- Conditions
- Healthy volunteers (intended for postoperative pain treatment in patients after total knee arthroplasty)Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]MedDRA version: 14.0Level: LLTClassification code 10054711Term: Postoperative painSystem Organ Class: 10022117 - Injury, poisoning and procedural complications
- Registration Number
- EUCTR2011-004285-15-DK
- Lead Sponsor
- Professor Jørgen Berg Dahl
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 12
Inclusion Criteria
- Age 18-30 years
- Men
- ASA 1
- BMI 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 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- Allergy to study medication
- Earlier trauma or surgery to lower limbs
- Diabetes Mellitus
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Our aim is to compare the effect of the Adductor-Canal-Blockade versus the femoral nerve block on muscle strength in healthy volunteers. Our hypothesis is that the Adductor-Canal-Blockade in a lesser degree compromises muscle strength compared to the femoral nerve block.;Secondary Objective: Our aim is to compare the effect of the Adductor-Canal-Blockade versus the femoral nerve block on mobilization in healthy volunteers. Our hypothesis is that the Adductor-Canal-Blockade in a lesser degree compromises mobilization compared to the femoral nerve block.;Primary end point(s): Difference in muscle strength between the Adductor-Canal-Blockade and the placebo group;Timepoint(s) of evaluation of this end point: Area under the curve (AUC) 30 minutes -6 hours
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Difference in muscle strength between the Adductor-Canal-Blockade and the femoral nerve group<br>Difference in muscle strength between the placebo and the femoral nerve group<br>Difference in the mobilization tests between the groups;Timepoint(s) of evaluation of this end point: Muscle strength: Area under the curve (AUC) 30 minutes -6 hours <br>Mobilization tests: 1 and 6 hours