Adductor-Canal-Blockade Versus the Femoral Nerve Block Effect on Muscle Strength and Mobilization in Healthy Volunteers

Healthy Volunteers Clinical Trial

Official title:

Comparison of the Efficacy of the Adductor-Canal-Blockade Versus the Femoral Nerve Block on Muscle Strength and Mobilization in Healthy Volunteers: a Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01449097
• Other study ID #: SM2-PJ-11
• Status: Completed
• Phase: Phase 4
• First received: October 6, 2011
• Last updated: December 21, 2011
• Start date: October 2011
• Est. completion date: November 2011

Study information

• Verified date: December 2011
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection AgencyDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate the efficacy of the Adductor-Canal-Blockade versus the femoral nerve block versus placebo on muscle strength in healthy volunteers. The investigators hypothesize that the Adductor-Canal-Blockade results in a lesser reduction of the quadriceps muscle strength compared to the femoral nerve block.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• written informed consent

• ASA 1

• BMI > 18 og < 25

Exclusion Criteria:

• Can not cooperate to the exam

• Do not speak or understand Danish

• Drug allergy

• Alcohol or drug abuse

• Daily consumption of analgetics on prescription

• Any drug intake within the last 48 hours

• Neuromuscular defects in the femoral nere, the obturator nerve or the muscles of the thigh.

• Previous surgery or trauma to the lower limb

• Diabetes Mellitus

• Intake of steroids, except steroids for inhalation

• Physical exercise within the last 24 hours prior to Day 1 and 2 of the study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers
• Muscle Strength

Intervention

Procedure:
• Adductor-Canal-Blockade
US-guided Adductor-Canal-blockade with Ropivacaine
• The femoral nerve block
US-guided femoral nerve block with ropivacaine
• Placebo
US-guided Adductor-Canal-Blockade/femoral nerve block with saline

Locations

Country	Name	City	State
Denmark	Department of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the difference in quadriceps muscle strength between the Adductor-Canal-Blockade and placebo		0-6 hours	No
Secondary	The difference in quadriceps muscle strength between the Adductor-Canal-Blockade and the femoral nerve block		0-6 hours	No
Secondary	The difference in quadriceps muscle strength between the placebo and the femoral nerve block		0-6 hours	No
Secondary	The difference in adductor muscle strength between the groups		0-6 hours	No
Secondary	The difference in mobilization between the groups		0-6 hours	No