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

April 12, 2011 updated by: Rigshospitalet, Denmark
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Glostrup, Denmark, 2600
        • Department of Surgery and Anaesthesia, Glostrup Hospital
    • Frederiksberg
      • Copenhagen, Frederiksberg, Denmark, 2000
        • Department of Anaesthesia, Privathospitalet Hamlet, Frederiksberg, Denmark

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • placebo block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total morphine consumption
Time Frame: 0-24 hours postoperative
Total morphine consumption at the interval 0-24 hours postoperative.
0-24 hours postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total morphine consumption
Time Frame: 0-26 hours postoperative
Total morphine consumption at the intervals 0-2, 0-4, 0-8 and 0-26 hours postoperative.
0-26 hours postoperative
Pain during rest
Time Frame: 0-26 hours postoperative
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.
0-26 hours postoperative
Pain during 45 degrees active flexion of the knee
Time Frame: 0-26 hours postoperative
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.
0-26 hours postoperative
A change in pain in the placebo group
Time Frame: 24-26 hours postoperative
0-100 mm at a visual analogue scale (VAS), at the intervals 24 and 26 hours postoperative.
24-26 hours postoperative
Postoperative nausea
Time Frame: 0-26 hours postoperative
Nausea scores(0-3)at 2,4,8,24,26 hours postoperative.
0-26 hours postoperative
Zofran consumption
Time Frame: 0-26 hours postoperative
Total zofran consumption at the intervals 0-24 and 24-26 hours postoperative.
0-26 hours postoperative
Sedation
Time Frame: 0-26 hours postoperative
Seadtion score (0-3) at 2,4,8,24,26 hours postoperative.
0-26 hours postoperative
Mobilisation
Time Frame: 20-26 hours postoperative
Number of seconds it takes to complete the "Timed Up and Go" test, at 20 and 26 hours postoperative.
20-26 hours postoperative
Postoperative vomiting
Time Frame: 0-26 hours postoperative
Number of vomiting episodes at the intervals 0-2,2-4,4-8,8-24,24-26 hours postoperative.
0-26 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (ACTUAL)

March 1, 2011

Study Completion (ACTUAL)

March 1, 2011

Study Registration Dates

First Submitted

April 12, 2010

First Submitted That Met QC Criteria

April 14, 2010

First Posted (ESTIMATE)

April 16, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 13, 2011

Last Update Submitted That Met QC Criteria

April 12, 2011

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SM1-PJ-2009
  • 2009-017794-37 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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