Adductor-Canal-Blockade Versus the Femoral Nerve Block Effect on Muscle Strength, Pain and Mobilization After Total Knee Replacement

December 17, 2012 updated by: Pia Jaeger, Rigshospitalet, Denmark

"A Comparison of the Efficacy of the Adductor-Canal-Blockade Versus the Femoral Nerve Block on Muscle Strength, Pain and Mobilization After Total Knee Arthroplasty: a Randomized Study

The aim of this study is to investigate the efficacy of the Adductor-Canal-Blockade versus the Femoral Nerve Block on muscle strength, pain and mobilization after total knee arthroplasty. We hypothesize that the Adductor-Canal-Blockade has the same effect on pain and morphine consumption as the Femoral Nerve Block, but without the same reduction in quadriceps muscle strength.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

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
      • Frederiksberg, Denmark, 2000
        • Department of Anaesthesia, Copenhagen University Hospital, Frederiksberg

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

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA 1-3
  • BMI > 18 og < 40
  • total knee arthroplasty in spinal anesthesia

Exclusion Criteria:

  • Can not cooperate to the exam
  • Do not speak or understand Danish
  • Drug allergy
  • Alcohol or drug abuse
  • Daily consumption of strong opioids
  • Rheumatoid arthritis
  • Intake of glucocorticoids
  • Effect of spinal anesthesia stopped prior to performing the regional block

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: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adductor-Canal-Blockade
Procedure: Adductor-Canal-Blockade
US-guided Adductor-Canal-Blockade with Ropivacaine
Active Comparator: Femoral Nerve Block
Procedure: 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 the femoral nerve block
Time Frame: 24 h postoperatively
24 h postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The difference in adductor muscle strength between the Adductor-Canal-Blockade and the Femoral Nerve Block
Time Frame: 24 h postoperatively
24 h postoperatively
Pain during flexion of the knee
Time Frame: 2-24 hours
0-100 mm at a visual analogue scale (VAS), calculated as the area under the curve for the interval 2-24 hours postoperatively.
2-24 hours
Pain at rest
Time Frame: 2-24 hours
0-100 mm at a visual analogue scale (VAS), calculated as the area under the curve for the interval 2-24 hours postoperatively.
2-24 hours
Total morphine consumption
Time Frame: 0-24 hours
0-24 hours
Postoperative nausea
Time Frame: 2-24 hours
2-24 hours
Postoperative vomiting
Time Frame: 0-24 hours
0-24 hours
Sedation
Time Frame: 2-24 hours
2-24 hours
Zofran consumption
Time Frame: 0-24 hours
Number of patients recieveing zofran postoperatively
0-24 hours
The difference in mobilization between the groups
Time Frame: 24 hours
24 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

November 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

November 9, 2011

First Submitted That Met QC Criteria

November 9, 2011

First Posted (Estimate)

November 11, 2011

Study Record Updates

Last Update Posted (Estimate)

December 18, 2012

Last Update Submitted That Met QC Criteria

December 17, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SM1-PJ-11

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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