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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014