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

October 3, 2011 updated by: Pia Jaeger, Rigshospitalet, Denmark
The objective of this study is to assess the efficacy of Adductor-Canal-Blockade on pain and morphine consumption after total knee arthroplasty. Our hypothesis is that the Adductor -Canal-Blockade is superior to placebo in reducing pain and morphine consumption after total knee arthroplasty.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

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
    • Hellerup
      • Gentofte, Hellerup, Denmark, 2900
        • Department of Anaesthesia-Surgery-Intensive Care, Gentofte Hospital

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

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Total Knee Arthroplasty in general 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

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Adductor-Canal-blockade with saline
Procedure: Adductor-Canal-blockade with saline
US-guided Adductor-Canal-blockade with saline
Other Names:
  • Sham block
Active Comparator: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain during 45 degrees active flexion of the knee
Time Frame: 1 hour postoperative
0-100 mm at a visual analogue scale (VAS), at 1 hour postoperative
1 hour postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain during 45 degrees active flexion of the knee
Time Frame: 0-6 hours postoperative
0-100 mm at a visual analogue scale (VAS), registered at the intervals 1, 2, 3, 4, 5 and 6 hours postoperative, calculated as "the area under the curve" (AUC) for the interval 1-6 hours postoperative.
0-6 hours postoperative
Pain during rest
Time Frame: 1-6 hours postoperative
0-100 mm at a visual analogue scale (VAS), registered at the intervals 1, 2, 3, 4, 5 and 6 hours postoperative, calculated as "the area under the curve" (AUC) for the interval 1-6 hours postoperative.
1-6 hours postoperative
A change in pain score in the ropivacaine group, after activating the block
Time Frame: 30-60 minutes postoperative
0-100 mm at a visual analogue scale (VAS), at 30 and 60 minutes postoperative. A change in pain score in the ropivacaine group compared to the placebo group, after activating the block.
30-60 minutes postoperative
Total morphine consumption
Time Frame: 30 minutes - 6 hours postoperative
Total morphine consumption at the interval 30 minutes - 6 hours postoperative.
30 minutes - 6 hours postoperative
Postoperative nausea
Time Frame: 1-6 hours postoperative
Nausea scores(0-3)registered at 1, 2, 3, 4, 5 and 6 hours postoperative, calculated as mean value for the interval 1-6 hours postoperative.
1-6 hours postoperative
Postoperative vomiting
Time Frame: 1-6 hours postoperative
Number of vomiting episodes at the interval 1-6 hours postoperative.
1-6 hours postoperative
Zofran consumption
Time Frame: 1-6 hours postoperative
Total zofran consumption at the intervals 1-6 hours postoperative.
1-6 hours postoperative
Sedation
Time Frame: 1-6 hours postoperative
Sedation score (0-3) registered at 1, 2, 3, 4, 5 and 6 hours postoperative, calculated as the mean value for the interval 1-6 hours postoperative.
1-6 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

January 1, 2011

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

December 16, 2010

First Submitted That Met QC Criteria

December 16, 2010

First Posted (Estimate)

December 17, 2010

Study Record Updates

Last Update Posted (Estimate)

October 4, 2011

Last Update Submitted That Met QC Criteria

October 3, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SM2-PJ-10
  • 2010-021918-30 (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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