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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01470391
First Posted: November 11, 2011
Last Update Posted: December 18, 2012
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 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.

Condition Intervention
Total Knee Arthroplasty Procedure: Adductor-Canal-Blockade Procedure: Femoral Nerve Block

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: "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

Resource links provided by NLM:


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 the femoral nerve block [ Time Frame: 24 h postoperatively ]

Secondary Outcome Measures:
  • The difference in adductor muscle strength between the Adductor-Canal-Blockade and the Femoral Nerve Block [ Time Frame: 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.

  • 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.

  • Total morphine consumption [ Time Frame: 0-24 hours ]
  • Postoperative nausea [ Time Frame: 2-24 hours ]
  • Postoperative vomiting [ Time Frame: 0-24 hours ]
  • Sedation [ Time Frame: 2-24 hours ]
  • Zofran consumption [ Time Frame: 0-24 hours ]
    Number of patients recieveing zofran postoperatively

  • The difference in mobilization between the groups [ Time Frame: 24 hours ]

Enrollment: 54
Study Start Date: November 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (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: Femoral Nerve Block Procedure: Femoral Nerve Block
US-guided Femoral Nerve Block with Ropivacaine

  Eligibility

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  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): NCT01470391


Locations
Denmark
Department of Anaesthesia, Copenhagen University Hospital, Frederiksberg
Frederiksberg, Denmark, 2000
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, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01470391     History of Changes
Other Study ID Numbers: SM1-PJ-11
First Submitted: November 9, 2011
First Posted: November 11, 2011
Last Update Posted: December 18, 2012
Last Verified: December 2012

Keywords provided by Pia Jaeger, Rigshospitalet, Denmark:
Adductor-Canal-Blockade
Femoral Nerve Block
Postoperative Pain
Total Knee Arthroplasty


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