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

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT01191593
Collaborator
(none)
36
Enrollment
1
Location
2
Arms
31
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Procedure: Adductor-Canal-Blockade with Ropivacaine
  • Procedure: Adductor-Canal-blockade with saline
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
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 Pain and Morphine Consumption After Revision Knee Arthroplasty
Study Start Date :
Sep 1, 2010
Actual Primary Completion Date :
Apr 1, 2013
Actual Study Completion Date :
Apr 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • Placebo block

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain during 45 degrees active flexion of the knee [4 hours postoperative]

      0-100 mm at a visual analogue scale (VAS), at 4 hours postoperative.

    Secondary Outcome Measures

    1. Pain during 45 degrees active flexion of the knee [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.

    2. Pain during 45 degrees active flexion of the knee [24 hours postoperative]

      0-100 mm at a visual analogue scale (VAS), at 24 hours postoperative.

    3. Pain during rest [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.

    4. Pain during rest [24 hours postoperative]

      0-100 mm at a visual analogue scale (VAS), at 24 hours postoperative.

    5. Total morphine consumption [0-24 hours postoperative]

      Total morphine consumption at the intervals 0-8, 8-24 and 0-24 hours postoperative.

    6. Postoperative nausea [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.

    7. Postoperative nausea [24 hours postoperative]

      Nausea score(0-3)at 24 hours postoperative.

    8. Postoperative vomiting [0-24 hours postoperative]

      Number of vomiting episodes at the intervals 0-8, 8-24 and 0-24 hours postoperative.

    9. Zofran consumption [0-24 hours postoperative]

      Total zofran consumption at the intervals 0-8, 8-24 and 0-24 hours postoperative.

    10. Sedation [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.

    11. Sedation [24 hours postoperative]

      Sedation score (0-3) at 24 hours postoperative.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Department of Anaesthesia and Surgery, HOC, Rigshospitalet, Denmark Copenhagen København Ø Denmark 2100

    Sponsors and Collaborators

    • Rigshospitalet, Denmark

    Investigators

    • Principal Investigator: Pia Jæger, MD, Rigshospitalet, Denmark

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pia Jaeger, M.D., Rigshospitalet, Denmark
    ClinicalTrials.gov Identifier:
    NCT01191593
    Other Study ID Numbers:
    • SM1-PJ-10
    • 2010-021161-71
    First Posted:
    Aug 31, 2010
    Last Update Posted:
    Aug 22, 2013
    Last Verified:
    Aug 1, 2013
    Keywords provided by Pia Jaeger, M.D., Rigshospitalet, Denmark
    Adductor-Canal-Blockade
    postoperative pain
    US-guided nerve block
    revision knee arthroplasty
    Additional relevant MeSH terms:
    Pain, Postoperative
    Ropivacaine

    Study Results

    No Results Posted as of Aug 22, 2013