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

This study has been completed.
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01104883
First received: April 12, 2010
Last updated: April 12, 2011
Last verified: April 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    Total morphine consumption at the interval 0-24 hours postoperative.


Secondary Outcome Measures:
  • Total morphine consumption [ Time Frame: 0-26 hours postoperative ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Nausea scores(0-3)at 2,4,8,24,26 hours postoperative.

  • Zofran consumption [ Time Frame: 0-26 hours postoperative ] [ Designated as safety issue: No ]
    Total zofran consumption at the intervals 0-24 and 24-26 hours postoperative.

  • Sedation [ Time Frame: 0-26 hours postoperative ] [ Designated as safety issue: No ]
    Seadtion score (0-3) at 2,4,8,24,26 hours postoperative.

  • Mobilisation [ Time Frame: 20-26 hours postoperative ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 12, 2010
Last Updated: April 12, 2011
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
total knee arthroplasty

ClinicalTrials.gov processed this record on September 18, 2014