We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01191593
First Posted: August 31, 2010
Last Update Posted: August 22, 2013
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 (Responsible Party):
Pia Jaeger, Rigshospitalet, Denmark
August 30, 2010
August 31, 2010
August 22, 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 ]
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 ]
    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 ]
    0-100 mm at a visual analogue scale (VAS), at 24 hours postoperative.
  • Pain during rest [ Time Frame: 1-8 hours postoperative ]
    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 ]
    0-100 mm at a visual analogue scale (VAS), at 24 hours postoperative.
  • Total morphine consumption [ Time Frame: 0-24 hours postoperative ]
    Total morphine consumption at the intervals 0-8, 8-24 and 0-24 hours postoperative.
  • Postoperative nausea [ Time Frame: 1-8 hours postoperative ]
    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 ]
    Nausea score(0-3)at 24 hours postoperative.
  • Postoperative vomiting [ Time Frame: 0-24 hours postoperative ]
    Number of vomiting episodes at the intervals 0-8, 8-24 and 0-24 hours postoperative.
  • Zofran consumption [ Time Frame: 0-24 hours postoperative ]
    Total zofran consumption at the intervals 0-8, 8-24 and 0-24 hours postoperative.
  • Sedation [ Time Frame: 1-8 hours postoperative ]
    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 ]
    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: Quadruple (Participant, Care Provider, 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
Jæger P, Koscielniak-Nielsen ZJ, Schrøder HM, Mathiesen O, Henningsen MH, Lund J, Jenstrup MT, Dahl JB. Adductor canal block for postoperative pain treatment after revision knee arthroplasty: a blinded, randomized, placebo-controlled study. PLoS One. 2014 Nov 11;9(11):e111951. doi: 10.1371/journal.pone.0111951. eCollection 2014.

*   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
Sexes Eligible for Study: All
40 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT01191593
SM1-PJ-10
2010-021161-71 ( EudraCT Number )
Yes
Not Provided
Not Provided
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