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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01449097
First Posted: October 7, 2011
Last Update Posted: December 22, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pia Jaeger, Rigshospitalet, Denmark
  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
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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 Pia Jaeger, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • the difference in quadriceps muscle strength between the Adductor-Canal-Blockade and placebo [ Time Frame: 0-6 hours ]

Secondary Outcome Measures:
  • The difference in quadriceps muscle strength between the Adductor-Canal-Blockade and the femoral nerve block [ Time Frame: 0-6 hours ]
  • The difference in quadriceps muscle strength between the placebo and the femoral nerve block [ Time Frame: 0-6 hours ]
  • The difference in adductor muscle strength between the groups [ Time Frame: 0-6 hours ]
  • The difference in mobilization between the groups [ Time Frame: 0-6 hours ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: October 6, 2011
First Posted: October 7, 2011
Last Update Posted: December 22, 2011
Last Verified: December 2011

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