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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pia Jaeger, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01191593
First received: August 30, 2010
Last updated: August 21, 2013
Last verified: August 2013

August 30, 2010
August 21, 2013
September 2010
April 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01191593 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Revision Knee Arthroplasty
The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Revision Knee Arthroplasty

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Postoperative Pain
  • Knee Arthroplasty
  • 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
  • Procedure: Adductor-Canal-blockade with saline
    US-guided Adductor-Canal-blockade with saline
    Other Name: Placebo block
  • Experimental: Adductor-Canal-Blockade with ropivacaine
    Intervention: Procedure: Adductor-Canal-Blockade with Ropivacaine
  • Placebo Comparator: Adductor-Canal-blockade with saline
    Intervention: Procedure: Adductor-Canal-blockade with saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
40 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01191593
SM1-PJ-10, 2010-021161-71
Yes
Pia Jaeger, Rigshospitalet, Denmark
Rigshospitalet, Denmark
Not Provided
Principal Investigator: Pia Jæger, MD Rigshospitalet, Denmark
Rigshospitalet, Denmark
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP