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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:
Information provided by (Responsible Party):
Pia Jaeger, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01470391
First received: November 9, 2011
Last updated: December 17, 2012
Last verified: December 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The difference in adductor muscle strength between the Adductor-Canal-Blockade and the Femoral Nerve Block [ Time Frame: 24 h postoperatively ] [ Designated as safety issue: No ]
  • Pain during flexion of the knee [ Time Frame: 2-24 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Postoperative nausea [ Time Frame: 2-24 hours ] [ Designated as safety issue: No ]
  • Postoperative vomiting [ Time Frame: 0-24 hours ] [ Designated as safety issue: No ]
  • Sedation [ Time Frame: 2-24 hours ] [ Designated as safety issue: No ]
  • Zofran consumption [ Time Frame: 0-24 hours ] [ Designated as safety issue: No ]
    Number of patients recieveing zofran postoperatively

  • The difference in mobilization between the groups [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided by Rigshospitalet, Denmark

Additional 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
Study First Received: November 9, 2011
Last Updated: December 17, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

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

ClinicalTrials.gov processed this record on November 25, 2014