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

December 21, 2011 updated by: Pia Jaeger, Rigshospitalet, Denmark

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Department of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Procedure: Placebo
US-guided Adductor-Canal-Blockade/femoral nerve block with saline
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the difference in quadriceps muscle strength between the Adductor-Canal-Blockade and placebo
Time Frame: 0-6 hours
0-6 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

October 6, 2011

First Submitted That Met QC Criteria

October 6, 2011

First Posted (Estimate)

October 7, 2011

Study Record Updates

Last Update Posted (Estimate)

December 22, 2011

Last Update Submitted That Met QC Criteria

December 21, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SM2-PJ-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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