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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pia Jaeger, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01449097
First received: October 6, 2011
Last updated: December 21, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Muscle Strength
Healthy Volunteers
Procedure: Adductor-Canal-Blockade
Procedure: The femoral nerve block
Procedure: Placebo
Phase 4

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

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • the difference in quadriceps muscle strength between the Adductor-Canal-Blockade and placebo [ Time Frame: 0-6 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The difference in quadriceps muscle strength between the Adductor-Canal-Blockade and the femoral nerve block [ Time Frame: 0-6 hours ] [ Designated as safety issue: No ]
  • The difference in quadriceps muscle strength between the placebo and the femoral nerve block [ Time Frame: 0-6 hours ] [ Designated as safety issue: No ]
  • The difference in adductor muscle strength between the groups [ Time Frame: 0-6 hours ] [ Designated as safety issue: No ]
  • The difference in mobilization between the groups [ Time Frame: 0-6 hours ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: October 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adductor-Canal-Blockade Procedure: Adductor-Canal-Blockade
US-guided Adductor-Canal-blockade with Ropivacaine
Active Comparator: The femoral nerve block Procedure: The femoral nerve block
US-guided femoral nerve block with ropivacaine
Placebo Comparator: Placebo Procedure: Placebo
US-guided Adductor-Canal-Blockade/femoral nerve block with saline

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01449097

Locations
Denmark
Department of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Pia Jæger, MD Rigshospitalet, Denmark
  More Information

No publications provided by Rigshospitalet, Denmark

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pia Jaeger, Principal investigator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01449097     History of Changes
Other Study ID Numbers: SM2-PJ-11
Study First Received: October 6, 2011
Last Updated: December 21, 2011
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency

Keywords provided by Rigshospitalet, Denmark:
Adductor-Canal-blockade,
human volunteers,
US-guided nerve block
femoral nerve block

ClinicalTrials.gov processed this record on April 15, 2014