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

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ClinicalTrials.gov Identifier: NCT01470391
Recruitment Status : Completed
First Posted : November 11, 2011
Last Update Posted : December 18, 2012
Sponsor:
Information provided by (Responsible Party):
Pia Jaeger, Rigshospitalet, Denmark

Brief Summary:
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 or disease Intervention/treatment Phase
Total Knee Arthroplasty Procedure: Adductor-Canal-Blockade Procedure: Femoral Nerve Block Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
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
Study Start Date : November 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

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




Primary Outcome Measures :
  1. The difference in quadriceps muscle strength between the Adductor-Canal-Blockade and the femoral nerve block [ Time Frame: 24 h postoperatively ]

Secondary Outcome Measures :
  1. The difference in adductor muscle strength between the Adductor-Canal-Blockade and the Femoral Nerve Block [ Time Frame: 24 h postoperatively ]
  2. 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.

  3. 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.

  4. Total morphine consumption [ Time Frame: 0-24 hours ]
  5. Postoperative nausea [ Time Frame: 2-24 hours ]
  6. Postoperative vomiting [ Time Frame: 0-24 hours ]
  7. Sedation [ Time Frame: 2-24 hours ]
  8. Zofran consumption [ Time Frame: 0-24 hours ]
    Number of patients recieveing zofran postoperatively

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


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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
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

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

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 Posted: November 11, 2011    Key Record Dates
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