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The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Revision Knee Arthroplasty

This study is currently recruiting participants.
Verified December 2012 by Rigshospitalet, Denmark
Sponsor:
Information provided by (Responsible Party):
Pia Jaeger, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01191593
First received: August 30, 2010
Last updated: December 17, 2012
Last verified: December 2012
History of Changes
  Purpose

The purpose of this study is to determine whether Adductor-Canal-Blockade is effective at reducing pain and morphine consumption after revision knee arthroplasty.


Condition Intervention Phase
Postoperative Pain
Knee Arthroplasty
 Procedure: Adductor-Canal-Blockade with Ropivacaine
Procedure: Adductor-Canal-blockade with saline
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Revision Knee Arthroplasty

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Pain during 45 degrees active flexion of the knee [ Time Frame: 4 hours postoperative ] [ Designated as safety issue: No ]
    0-100 mm at a visual analogue scale (VAS), at 4 hours postoperative.


Secondary Outcome Measures:
  • Pain during 45 degrees active flexion of the knee [ Time Frame: 1-8 hours postoperative ] [ Designated as safety issue: No ]
    0-100 mm at a visual analogue scale (VAS), registered at the intervals 1, 2, 4, 6 and 8 hours postoperative, calculated as "the area under the curve" (AUC) for the interval 1-8 hours postoperative.

  • Pain during 45 degrees active flexion of the knee [ Time Frame: 24 hours postoperative ] [ Designated as safety issue: No ]
    0-100 mm at a visual analogue scale (VAS), at 24 hours postoperative.

  • Pain during rest [ Time Frame: 1-8 hours postoperative ] [ Designated as safety issue: No ]
    0-100 mm at a visual analogue scale (VAS), registered at the intervals 1, 2, 4, 6 and 8 hours postoperative, calculated as "the area under the curve" (AUC) for the interval 1-8 hours postoperative.

  • Pain during rest [ Time Frame: 24 hours postoperative ] [ Designated as safety issue: No ]
    0-100 mm at a visual analogue scale (VAS), at 24 hours postoperative.

  • Total morphine consumption [ Time Frame: 0-24 hours postoperative ] [ Designated as safety issue: No ]
    Total morphine consumption at the intervals 0-8, 8-24 and 0-24 hours postoperative.

  • Postoperative nausea [ Time Frame: 1-8 hours postoperative ] [ Designated as safety issue: No ]
    Nausea scores(0-3)registered at 1,2,4,6 and 8 hours postoperative, calculated as mean value for the interval 1-8 hours postoperative.

  • Postoperative nausea [ Time Frame: 24 hours postoperative ] [ Designated as safety issue: No ]
    Nausea score(0-3)at 24 hours postoperative.

  • Postoperative vomiting [ Time Frame: 0-24 hours postoperative ] [ Designated as safety issue: No ]
    Number of vomiting episodes at the intervals 0-8, 8-24 and 0-24 hours postoperative.

  • Zofran consumption [ Time Frame: 0-24 hours postoperative ] [ Designated as safety issue: No ]
    Total zofran consumption at the intervals 0-8, 8-24 and 0-24 hours postoperative.

  • Sedation [ Time Frame: 1-8 hours postoperative ] [ Designated as safety issue: No ]
    Sedation score (0-3) registered at 1,2,4,6 and 8 hours postoperative, calculated as the mean value for the interval 1-8 hours postoperative.

  • Sedation [ Time Frame: 24 hours postoperative ] [ Designated as safety issue: No ]
    Sedation score (0-3) at 24 hours postoperative.


Estimated Enrollment: 36
Study Start Date: September 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adductor-Canal-Blockade with ropivacaine Procedure: Adductor-Canal-Blockade with Ropivacaine
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 Procedure: Adductor-Canal-blockade with saline
US-guided Adductor-Canal-blockade with saline
Other Name: Placebo block

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Revision Knee Arthroplasty in general anaesthesia
  • American society of anesthesiologists (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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01191593

Contacts
Contact: Pia Jæger, MD 0045 3545 3487 pia.jaeger@rh.regionh.dk
Contact: Jørgen B. Dahl, MD, DMSc,MBAex 0045 3545 8837 joergen.b.dahl@rh.regionh.dk

Locations
Denmark
Department of Anaesthesia and Surgery, HOC, Rigshospitalet, Denmark Recruiting
Copenhagen, København Ø, Denmark, 2100
Contact: Pia Jæger, MD     0045 3545 3487     pia.jaeger@rh.regionh.dk    
Contact: Jørgen B. Dahl, MD, DMSc, MBAex     0045 3545 8837     joergen.b.dahl@rh.regionh.dk    
Principal Investigator: Pia Jæger, MD            
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Pia Jæger, MD Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Pia Jaeger, M.D., Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01191593     History of Changes
Other Study ID Numbers: SM1-PJ-10, 2010-021161-71
Study First Received: August 30, 2010
Last Updated: December 17, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency

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

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Morphine
Ropivacaine
Analgesics, Opioid
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics
Anesthetics, Local
Anesthetics

ClinicalTrials.gov processed this record on June 13, 2013