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The Efficacy of Adductor-Canal-Blockade on Morphine Consumption, Pain and Mobilisation After Total Knee Arthroplasty

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01104883
First Posted: April 16, 2010
Last Update Posted: April 13, 2011
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:
Rigshospitalet, Denmark
  Purpose
The purpose of this study is to determine whether Adductor-Canal-Blockade is effective at reducing morphine consumption and pain, and at the same time improving mobilisation after total knee arthroplasty.

Condition Intervention Phase
Total Knee Arthroplasty Procedure: Adductor-Canal-Blockade Procedure: Adductor-Canal-blockade with saline Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Adductor-Canal-Blockade on Morphine Consumption, Pain and Mobilisation After Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Total morphine consumption [ Time Frame: 0-24 hours postoperative ]
    Total morphine consumption at the interval 0-24 hours postoperative.


Secondary Outcome Measures:
  • Total morphine consumption [ Time Frame: 0-26 hours postoperative ]
    Total morphine consumption at the intervals 0-2, 0-4, 0-8 and 0-26 hours postoperative.

  • Pain during rest [ Time Frame: 0-26 hours postoperative ]
    0-100 mm at a visual analogue scale (VAS), at the intervals 2, 4, 8, 24 and 26 hours postoperative, and the area under the curve for the intervals 2-24 and 24-26 hours postoperative.

  • Pain during 45 degrees active flexion of the knee [ Time Frame: 0-26 hours postoperative ]
    0-100 mm at a visual analogue scale (VAS), at the intervals 2, 4, 8, 24 and 26 hours postoperative, and the area under the curve for the intervals 2-24 and 24-26 hours postoperative.

  • A change in pain in the placebo group [ Time Frame: 24-26 hours postoperative ]
    0-100 mm at a visual analogue scale (VAS), at the intervals 24 and 26 hours postoperative.

  • Postoperative nausea [ Time Frame: 0-26 hours postoperative ]
    Nausea scores(0-3)at 2,4,8,24,26 hours postoperative.

  • Zofran consumption [ Time Frame: 0-26 hours postoperative ]
    Total zofran consumption at the intervals 0-24 and 24-26 hours postoperative.

  • Sedation [ Time Frame: 0-26 hours postoperative ]
    Seadtion score (0-3) at 2,4,8,24,26 hours postoperative.

  • Mobilisation [ Time Frame: 20-26 hours postoperative ]
    Number of seconds it takes to complete the "Timed Up and Go" test, at 20 and 26 hours postoperative.

  • Postoperative vomiting [ Time Frame: 0-26 hours postoperative ]
    Number of vomiting episodes at the intervals 0-2,2-4,4-8,8-24,24-26 hours postoperative.


Estimated Enrollment: 70
Study Start Date: August 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adductor-Canal-Blockade
Adductor-Canal-Blockade with ropivacaine
Procedure: Adductor-Canal-Blockade
US-guided Adductor-Canal-Blockade with ropivacaine 7,5 mg/ml
Other Names:
  • Naropine
  • Postoperative pain
  • US-guided nerve block
Placebo Comparator: Adductor-Canal-blockade with saline
Adductor-Canal-blockade with isotonic saline
Procedure: Adductor-Canal-blockade with saline
US-guided Adductor-Canal-blockade with saline
Other Name: placebo block

  Eligibility

Information from the National Library of Medicine

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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:

  • Total Knee Arthroplasty in spinal anaesthesia
  • ASA 1-3
  • BMI 18-40
  • Written informed consent

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
  • Unable to complete the Timed Up and Go test preoperatively
  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): NCT01104883


Locations
Denmark
Department of Anaesthesia, Privathospitalet Hamlet, Frederiksberg, Denmark
Copenhagen, Frederiksberg, Denmark, 2000
Department of Surgery and Anaesthesia, Glostrup Hospital
Glostrup, Denmark, 2600
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, Department of Anaesthesia, Centre of Head and Orthopaedics, Rigshospitalet, Copenhagen, Denmark
ClinicalTrials.gov Identifier: NCT01104883     History of Changes
Other Study ID Numbers: SM1-PJ-2009
2009-017794-37 ( EudraCT Number )
First Submitted: April 12, 2010
First Posted: April 16, 2010
Last Update Posted: April 13, 2011
Last Verified: April 2010

Keywords provided by Rigshospitalet, Denmark:
Adductor-Canal-Blockade
postoperative pain
US-guided nerve block
total knee arthroplasty

Additional relevant MeSH terms:
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents